• FDA Basics: Norman Baylor, PhD on Vaccines

    Norman Baylor is director of the Office of Vaccines Research Review in the Center for Biologics Evaluation and Research. Among other things, Baylor talks about the special talents of his team. "Most of our staff," says Baylor in this interview, "started in a laboratory or in a clinical setting, a hospital or some other clinical setting, so we have ... the ability and the knowledge base to evaluate these products. And even when new technologies come about, we have the knowledge base to understand and to ask the appropriate questions about how these products might work, how these technologies might be applied to these different products. Visit FDA Basics for more information at: http://www.fda.gov/FDABasics [vpbiologicsbloodvaccines]

    published: 06 Jan 2010
  • FDA monitoring C2 drinks after recall in Vietnam

    Days after Vietnam's health department recalled C2 beverages, which supposedly contain high amounts of lead, the Food and Drug Administration tells local consumers they have nothing to worry about. - Business Nightly, ANC, May 30, 2016 Subscribe to the ABS-CBN News channel! - http://bit.ly/TheABSCBNNews Visit our website at http://news.abs-cbn.com Facebook: https://www.facebook.com/abscbnNEWS Twitter: https://twitter.com/abscbnnews

    published: 30 May 2016
  • Globe rupture / Severe eye injury and surgical repair - A State of Sight #103

    An extreme eye injury can cause a globe rupture where the eyeball can split open. This can be due to trauma directly on the eye or around the eye. Watch this episode of A State of Sight with Isaac Porter, MD to learn more about this injury and the eye surgery options to help save the eye and restore vision. http://eyePorter.com http://google.com/+IsaacPorterMD http://facebook.com/eyeporter twitter @eyeporter

    published: 24 Feb 2015
  • The FDA Wants To Ban Soap?!

    The FDA is proposing a ban on antibacterial soaps unless the manufacturers can prove its efficacy, which is a word not used enough. Efficacy efficacy efficacy. Buy some awesomeness for yourself! http://www.forhumanpeoples.com/collections/sourcefed Our Sources: http://b.globe.com/1k96976 More stories at: http://www.sourcefed.com or check out: http://youtube.com/sourcefed for our 5 daily videos or anything else we've ever done. Follow us on Twitter: http://twitter.com/sourcefed Follow us on Tumblr: http://sourcefed.tumblr.com/ Like us on Facebook: http://on.fb.me/xQDV8M Philly D OFFICIAL APP for instant updates: http://bit.ly/aIyY0w Get your SourceFed Posters here: http://bit.ly/SourceFedPosters P.O. Box address: Attention: SourceFed 6433 Topanga Canyon Blvd. #805 Canoga Park, CA 9130...

    published: 17 Dec 2013
  • Can You Make an Accurate Map?

    Earth is not flat. So, representing it on a flat surface can be challenging and always requires compromises. Hosted by: Hank Green ---------- Support SciShow by becoming a patron on Patreon: https://www.patreon.com/scishow ---------- Dooblydoo thanks go to the following Patreon supporters—we couldn't make SciShow without them! Shout out to Kevin Bealer, Mark Terrio-Cameron, KatieMarie Magnone, Patrick Merrithew, Charles Southerland, Fatima Iqbal, Benny, Kyle Anderson, Tim Curwick, Scott Satovsky Jr, Philippe von Bergen, Bella Nash, Bryce Daifuku, Chris Peters, Patrick D. Ashmore, Charles George, Bader AlGhamdi ---------- Looking for SciShow elsewhere on the internet? Facebook: http://www.facebook.com/scishow Twitter: http://www.twitter.com/scishow Tumblr: http://scishow.tumblr.com Instagr...

    published: 05 Mar 2017
  • Headlines at 8:30: FDA to update nutrition food labels

    "CBS This Morning" takes a look at some of the day's headlines from around the globe.

    published: 24 Jan 2014
  • 24 Oras: FDA, nagbabala kontra sa mura pero maruming bottled water

    24 Oras is GMA Network's flagship newscast, anchored by Mike Enriquez and Mel Tiangco. It airs on GMA-7 Mondays to Fridays at 6:30 PM (PHL Time) and on weekends at 5:30 PM. For more videos from 24 Oras, visit http://www.gmanetwork.com/24oras. GMA News Online: http://www.gmanews.tv Facebook: http://www.facebook.com/gmanews Twitter: http://www.twitter.com/gmanews

    published: 09 Apr 2014
  • Implementing Digital Signatures in an FDA-Regulated Environment

    Learn how your organization can benefit from a digital signature solution. -- Perficient’s life sciences practice once had a manual, time-consuming and expensive process for signing and collecting validation documents. From handwritten signatures to scanning and shipping documents all over the globe, it was only a matter of time before we made the move to 21 CFR Part 11-compliant digital signatures. Michelle Engler, an expert in the development of clinical applications, discussed our experience implementing a digital signature solution and how your organization can benefit from one too. During the presentation, we covered: -- Cost-benefit analysis -- Solution selection and implementation -- 21 CFR Part 11 system validation -- Lessons learned To view this webinar in its entirety, ple...

    published: 18 Dec 2014
  • FDA Vaping Regulations: HARDTALK

    Excerpts from a Spanish talk-show🔼 on FDA deeming regulations for e-cigarettes. CONNECT WITH ME THRU: 1) Facebook: https://www.facebook.com/qorax.stan 2) ECF: https://www.e-cigarette-forum.com/forum/members/qorax.124295/ MUSIC CREDITS: 1) Don - The Theme, by Darrel Mascarenhas 2) Don - Exclusive, by Instrumental Gravity 3) Various* by Kevin MacLeod, via Incompetech *Various sound clips of Kevin MacLeod (incompetech.com) Licensed under Creative Commons: By Attribution 3.0 License http://creativecommons.org/licenses/by/3.0/ --------------------------------------------------------------------------- COPYRIGHT DISCLAIMER: "Under Section 107 of the Copyright Act 1976, allowance is made for "fair use" of some external content/s in this video, as listed above. This is for purposes such as c...

    published: 25 Apr 2017
  • FDA: Limit BPA Consumption

    The Food and Drug Administration is now warning to limit BPA consumption, a common chemical in canned foods. As Kelly Wallace reports, BPA is normally not labeled on products.

    published: 18 Jan 2010
  • OUTBREAK 2016! FDA RELEASES GMO MOSQUITOES!!

    FOOLED, BAMBOOZLED, SPRAYED AND NOW HERE COME THE GMO MOSQUITOES NEVER BEFORE RELEASED IN THE U.S.(OVERTLY THAT IS) RFB http://www.the-news-daily.com/_601738 NEWS DAILY http://www.sun-sentinel.com/health/fl... SUN SENTINEL http://abcnews.go.com/Health/fda-gmo-... ABC/FDA APPROVES!!! Disclaimer: All works by RichieFromBoston are criticism, comment, news reporting, teaching and research. -All footage taken falls under ''fair use'' of the Digital Millennium Copyright Act (1998). Therefore, no breach of privacy or copyright has been committed. -FAIR USE STATEMENT This video may contain copyrighted material the use of which has not been specifically authorized by the copyright owner. This material is being made available within this transformative or derivative work for the purpose of education...

    published: 05 Aug 2016
  • FDA Panel Rejects Gouty Arthritis Drug

    Safety concerns, not treatment effectiveness, prompted the Food and Drug Administration's Arthritis Advisory Committee to vote 11-1 that the data on canakinumab did not support the biologic's approval as a treatment for gouty arthritis attacks in patients who have not responded adequately to nonsteroidal anti-inflammatory drugs or colchicine. See the related story at http://tinyurl.com/5ururvb

    published: 22 Jun 2011
  • How the FDA Supports Big Food Companies in Selling More Junk Food - Dr. Rob Verkerk

    Visit our website: http://www.thetruthaboutcancer.com/ Join TTAC's 500K+ FB fans: https://www.facebook.com/thetruthabou... Support our mission by commenting and sharing with your friends and family below. ---------------- Summary ---------------- In this video, cancer researcher Ty Bollinger (off camera) speaks with Dr. Robert Verkerk, PhD, Executive Director of Alliance for Natural Health-International. Dr. Verkerk shares how the food policies of the FDA and the European Commission benefit big food companies. The full interview with Dr. Verkerk is part of "The Quest For The Cures Continues" docu-series. -------------------------------------------------- About The Truth About Cancer -------------------------------------------------- The Truth About Cancer’s mission is to inform, educate...

    published: 25 Feb 2016
  • A Brilliant Lie.

    The deeming FDA regulations (and TPD, its counterpart in the EU) is out to ruin an otherwise productive and effective revolution – Vaping. Lobbying, manipulation and disinformation is the name of the game. It's an absurd, perverse government failure – and there's no respite in sight. PAYING TRIBUTE TO: 1) Aaron Biebert: https://www.youtube.com/watch?v=zSq9iqal2cA 2) Laura Pausini: https://www.youtube.com/watch?v=ZHVdScgUm7U&list=RDZHVdScgUm7U CONNECT WITH ME THRU: 1) Facebook: https://www.facebook.com/qorax.stan 2) ECF: https://www.e-cigarette-forum.com/forum/members/qorax.124295/ REFERENCES: 1) http://www.maciverinstitute.com/2017/03/fda-regulations-ready-to-steamroll-small-vape-shops/ 2) http://fdaregs.info/fda-deeming-regulations/timeline/ 3) https://chemular.com/blogs/news/11691482...

    published: 10 Apr 2017
  • 10 Weird SCHOOL RULES from Around the World

    top 10 rules students need to follow from schools in other countries Subscribe to our channel: http://goo.gl/9CwQhg For copyright matters please contact us at: david.f@valnetinc.com Description: In order for a school to function properly, rules have to be set into motion. Otherwise, total anarchy and chaos could ensue. Most rules are pretty simple as they revolve around the concept of respect in terms of respecting the teacher and students respecting each other so that there can be a productive learning environment. However, there are some schools that want to exercise more control, and they start to break the boundaries of personal space and living realistically. Some of these rules include unbalanced dress codes where girls have to cover as much of their body as possible while boys are...

    published: 04 Oct 2016
  • Medical Device Supplier Qualification and Management

    Medical Device Supplier Qualification and Management — Practical Approaches to Cost Effective Implementation Regulators around the globe are looking more closely at supplier management issues as device manufacturers extend their processes down the supply chain and acquire components across national boundaries. Are you ready for the increased scrutiny from FDA Investigators and Notified Bodies? You can start to prepare with important GHTF guidance documents: Control of Suppliers (GHTF/SG3/N17:2008), Risk Management Principles in a QMS (GHTF/SG3/N15R8), and Corrective Action & Preventive Action in a QMS (GHTF/SG3/N18:2010). These guidance documents provide the foundation, but lack practical details. This workshop gives you the tools and methods you need for a cost effective implementation. ...

    published: 10 Feb 2015
  • Rexahn Receives FDA Orphan Drug Designation for RX-3117 in Treatment of Pancreatic Cancer

    ROCKVILLE, Md., Sept. 24, 2014 (GLOBE NEWSWIRE) -- Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN), a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its drug RX-3117 for the treatment of patients with pancreatic cancer. RX-3117 is a next generation, cancer-specific nucleoside analog. Rexahn is currently enrolling patients in a Phase Ib clinical trial in cancer patients and expects to complete this trial in the first quarter of 2015. The FDA's office of Orphan Drug Products grants orphan status to support development of medicines for rare disorders, defined as diseases that affect fewer than 200,000 people in the United States. Or...

    published: 26 Sep 2014
  • The Mysterious Poisoned Pill Murders

    The incidents depicted happened 35 years ago. Johnson & Johnson has since introduced safety measures which have set the industry standard and established the company as a model for safety. Check out more awesome videos at BuzzFeedBlue! https://bit.ly/YTbuzzfeedvideo https://bit.ly/YTbuzzfeedblue1 https://bit.ly/YTbuzzfeedviolet GET MORE BUZZFEED: https://www.buzzfeed.com https://www.buzzfeed.com/videos https://www.youtube.com/buzzfeedvideo https://www.youtube.com/boldly https://www.youtube.com/buzzfeedblue https://www.youtube.com/buzzfeedviolet https://www.youtube.com/perolike https://www.youtube.com/ladylike BuzzFeedBlue Sports, video games, Unsolved & more epic daily videos! Credits: https://www.buzzfeed.com/bfmp/videos/30554 MUSIC Licensed via Audio Network SFX Provided By AudioBlo...

    published: 16 Sep 2017
  • FDA proposes ban on trans fat in foods

    The US Food and Drug Administration has taken a bold step to remove trans fats from the food supply issuing a proposed regulation Thursday that would remove the artificially manufactured fats from its list of ingredients "generally recognized as safe." While many food manufacturers have already removed partially hydrogenated oils from their products, many still use them in sweetened baked goods, margarine, microwave popcorn, frozen pizzas, and coffee creamers. "While consumption of potentially harmful artificial trans fat has declined over the last two decades in the United States, current intake remains a significant public health concern," said FDA Commissioner Dr. Margaret Hamburg. "Further reduction in the amount of trans fat in the American diet could prevent an additional 20,000 he...

    published: 07 Nov 2013
  • Precise Science - FDA

    Precise Science - FDA

    published: 07 Jul 2015
  • The Race To Yes FDA Ad Comm Video

    The Race to Yes Urges FDA to Use the Evidence Presented by Dozens of Scientists, Physicians, Patients and Advocates as Required by 2012 FDASIA Act for Conditional Approval Experts Remind Duchenne Community that Ad Comm Vote on accelerated approval was very close (6 yes-7 no); FDA Can Still Make Right Decision to Approve the Drug Physicians and scientists who have studied Duchenne muscular dystrophy and treated patients for decades presented compelling evidence that a new Duchenne drug, eteplirsen, works during the open public hearing section of a U.S. Food and Drug Administration (FDA) Advisory Committee Meeting (Ad Comm). They were part of an unprecedented crowd of more than 800 people imploring the FDA panel to see past rigid rules created for mass population drugs and listen to the sc...

    published: 12 May 2016
  • TITAN GEL FOR MEN 09954040945 / 09954040945 FDA Approve 100% no side Titan Gel Philippines

    Good Day, - - - - - P L E A S E R E A D - - - - Today we are selling Titan Gel (Tantra Gel for Men) : Special Gel for Penis. To order, PM us through our Social Network (Facebook) Page @ www.facebook.com/TitanGelPhilippines2018 and/or www.facebook.com/TitanGelOnlinePH . Just click the blue highlighted link. Send us a message with the following format on how to order: How to Order: (Please follow the Step by Step Guide below, on how to Place your Order) Step 1: Send us a Text Message for the Number of Titan Gel you want to order,complete name and address. Ex. “Hi, I would like to order 5 tubes Titan Gel, I’m Juan De La Cruz from brgy. ll Baker Street, Manila City” and Send to 09954040945 (Globe or any network) Please wait for confirmation within 1-2 hours (Usual...

    published: 23 Mar 2017
  • Headlines: FDA approves device to counter heroin overdose

    "CBS This Morning" takes a look at some of the headlines from around the globe.

    published: 04 Apr 2014
  • Pluristem and NIAID Met With U.S. FDA and Agreed on Development Plan

    HAIFA, Israel, Sept. 21, 2015 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (PSTI.TA) (PSTI.TA), a leading developer of placenta-based cell therapy products, announced today that Pluristem and the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH), completed a successful meeting with the U.S. Food and Drug Administration (FDA) regarding the development program for PLX-R18 cells in the treatment of Acute Radiation Syndrome (ARS). ARS is caused by exposure to dangerously high levels of radiation, such as those that could occur in a nuclear catastrophe. The FDA communicated that the data presented at the meeting allow for the design of large animal studies, which are the only studies required to prove efficacy for FDA approval un...

    published: 30 Sep 2015
FDA Basics: Norman Baylor, PhD on Vaccines

FDA Basics: Norman Baylor, PhD on Vaccines

  • Order:
  • Duration: 6:28
  • Updated: 06 Jan 2010
  • views: 4161
videos
Norman Baylor is director of the Office of Vaccines Research Review in the Center for Biologics Evaluation and Research. Among other things, Baylor talks about the special talents of his team. "Most of our staff," says Baylor in this interview, "started in a laboratory or in a clinical setting, a hospital or some other clinical setting, so we have ... the ability and the knowledge base to evaluate these products. And even when new technologies come about, we have the knowledge base to understand and to ask the appropriate questions about how these products might work, how these technologies might be applied to these different products. Visit FDA Basics for more information at: http://www.fda.gov/FDABasics [vpbiologicsbloodvaccines]
https://wn.com/Fda_Basics_Norman_Baylor,_Phd_On_Vaccines
FDA monitoring C2 drinks after recall in Vietnam

FDA monitoring C2 drinks after recall in Vietnam

  • Order:
  • Duration: 1:32
  • Updated: 30 May 2016
  • views: 9913
videos
Days after Vietnam's health department recalled C2 beverages, which supposedly contain high amounts of lead, the Food and Drug Administration tells local consumers they have nothing to worry about. - Business Nightly, ANC, May 30, 2016 Subscribe to the ABS-CBN News channel! - http://bit.ly/TheABSCBNNews Visit our website at http://news.abs-cbn.com Facebook: https://www.facebook.com/abscbnNEWS Twitter: https://twitter.com/abscbnnews
https://wn.com/Fda_Monitoring_C2_Drinks_After_Recall_In_Vietnam
Globe rupture / Severe eye injury and surgical repair - A State of Sight #103

Globe rupture / Severe eye injury and surgical repair - A State of Sight #103

  • Order:
  • Duration: 2:58
  • Updated: 24 Feb 2015
  • views: 3790
videos
An extreme eye injury can cause a globe rupture where the eyeball can split open. This can be due to trauma directly on the eye or around the eye. Watch this episode of A State of Sight with Isaac Porter, MD to learn more about this injury and the eye surgery options to help save the eye and restore vision. http://eyePorter.com http://google.com/+IsaacPorterMD http://facebook.com/eyeporter twitter @eyeporter
https://wn.com/Globe_Rupture_Severe_Eye_Injury_And_Surgical_Repair_A_State_Of_Sight_103
The FDA Wants To Ban Soap?!

The FDA Wants To Ban Soap?!

  • Order:
  • Duration: 1:49
  • Updated: 17 Dec 2013
  • views: 109171
videos
The FDA is proposing a ban on antibacterial soaps unless the manufacturers can prove its efficacy, which is a word not used enough. Efficacy efficacy efficacy. Buy some awesomeness for yourself! http://www.forhumanpeoples.com/collections/sourcefed Our Sources: http://b.globe.com/1k96976 More stories at: http://www.sourcefed.com or check out: http://youtube.com/sourcefed for our 5 daily videos or anything else we've ever done. Follow us on Twitter: http://twitter.com/sourcefed Follow us on Tumblr: http://sourcefed.tumblr.com/ Like us on Facebook: http://on.fb.me/xQDV8M Philly D OFFICIAL APP for instant updates: http://bit.ly/aIyY0w Get your SourceFed Posters here: http://bit.ly/SourceFedPosters P.O. Box address: Attention: SourceFed 6433 Topanga Canyon Blvd. #805 Canoga Park, CA 91303 The @SourceFed Host: @elliottcmorgan Music: @ronaldjenkees, @Hagemeister
https://wn.com/The_Fda_Wants_To_Ban_Soap
Can You Make an Accurate Map?

Can You Make an Accurate Map?

  • Order:
  • Duration: 4:34
  • Updated: 05 Mar 2017
  • views: 285587
videos
Earth is not flat. So, representing it on a flat surface can be challenging and always requires compromises. Hosted by: Hank Green ---------- Support SciShow by becoming a patron on Patreon: https://www.patreon.com/scishow ---------- Dooblydoo thanks go to the following Patreon supporters—we couldn't make SciShow without them! Shout out to Kevin Bealer, Mark Terrio-Cameron, KatieMarie Magnone, Patrick Merrithew, Charles Southerland, Fatima Iqbal, Benny, Kyle Anderson, Tim Curwick, Scott Satovsky Jr, Philippe von Bergen, Bella Nash, Bryce Daifuku, Chris Peters, Patrick D. Ashmore, Charles George, Bader AlGhamdi ---------- Looking for SciShow elsewhere on the internet? Facebook: http://www.facebook.com/scishow Twitter: http://www.twitter.com/scishow Tumblr: http://scishow.tumblr.com Instagram: http://instagram.com/thescishow ---------- Sources: http://www.users.miamioh.edu/shermalw/honors_2001_fall/honors_papers_2001/pettita_2001.html http://www.icsm.gov.au/mapping/map_projections.html http://nationalgeographic.org/activity/investigating-map-projections/ http://www.progonos.com/furuti/MapProj/Normal/ProjCyl/ProjCEA/projCEA.html http://xkcd.com/977/ http://www.businessinsider.com/mercator-projection-v-gall-peters-projection-2013-12?r=US&IR=T&IR=T http://www.winkel.org/other/Winkel%20Tripel%20Projections.htm Images: https://commons.wikimedia.org/wiki/File:AnAlbumOfMapProjections.pdf https://commons.wikimedia.org/wiki/File:Mercator-projection.jpg https://commons.wikimedia.org/wiki/File:Mercator_projection_SW.jpg https://ccsearch.creativecommons.org/image/detail/lGQeoEbPt2fwAzpFyA03Aw== https://commons.wikimedia.org/wiki/File:Tissot_mercator.png https://commons.wikimedia.org/wiki/File:Lambert-cylindrical-equal-area-projection.jpg https://commons.wikimedia.org/wiki/File:Cilinderprojectie-constructie.jpg https://commons.wikimedia.org/wiki/File:Tissot_indicatrix_world_map_Lambert_cyl_equal-area_proj.svg https://commons.wikimedia.org/wiki/File:Winkel-tripel-projection.jpg https://commons.wikimedia.org/wiki/File:Aitoff-projection.jpg https://commons.wikimedia.org/wiki/File:Equirectangular_projection_SW.jpg https://commons.wikimedia.org/wiki/File:Tissot_indicatrix_world_map_Winkel_Tripel_proj.svg https://commons.wikimedia.org/wiki/File:Dymaxion_2003_animation_small1.gif https://commons.wikimedia.org/wiki/File:Fuller_projection_with_Tissot%27s_indicatrix_of_deformation.png https://commons.wikimedia.org/wiki/File:Map-of-human-migrations.jpg https://commons.wikimedia.org/wiki/File:John_Newton_and_William_Palmer_SLNSW_globe_1782.jpg
https://wn.com/Can_You_Make_An_Accurate_Map
Headlines at 8:30: FDA to update nutrition food labels

Headlines at 8:30: FDA to update nutrition food labels

  • Order:
  • Duration: 2:07
  • Updated: 24 Jan 2014
  • views: 207
videos
"CBS This Morning" takes a look at some of the day's headlines from around the globe.
https://wn.com/Headlines_At_8_30_Fda_To_Update_Nutrition_Food_Labels
24 Oras: FDA, nagbabala kontra sa mura pero maruming bottled water

24 Oras: FDA, nagbabala kontra sa mura pero maruming bottled water

  • Order:
  • Duration: 3:01
  • Updated: 09 Apr 2014
  • views: 2209
videos
24 Oras is GMA Network's flagship newscast, anchored by Mike Enriquez and Mel Tiangco. It airs on GMA-7 Mondays to Fridays at 6:30 PM (PHL Time) and on weekends at 5:30 PM. For more videos from 24 Oras, visit http://www.gmanetwork.com/24oras. GMA News Online: http://www.gmanews.tv Facebook: http://www.facebook.com/gmanews Twitter: http://www.twitter.com/gmanews
https://wn.com/24_Oras_Fda,_Nagbabala_Kontra_Sa_Mura_Pero_Maruming_Bottled_Water
Implementing Digital Signatures in an FDA-Regulated Environment

Implementing Digital Signatures in an FDA-Regulated Environment

  • Order:
  • Duration: 58:22
  • Updated: 18 Dec 2014
  • views: 294
videos
Learn how your organization can benefit from a digital signature solution. -- Perficient’s life sciences practice once had a manual, time-consuming and expensive process for signing and collecting validation documents. From handwritten signatures to scanning and shipping documents all over the globe, it was only a matter of time before we made the move to 21 CFR Part 11-compliant digital signatures. Michelle Engler, an expert in the development of clinical applications, discussed our experience implementing a digital signature solution and how your organization can benefit from one too. During the presentation, we covered: -- Cost-benefit analysis -- Solution selection and implementation -- 21 CFR Part 11 system validation -- Lessons learned To view this webinar in its entirety, please visit: http://www.perficient.com/Thought-Leadership/On-Demand-Webinars/2014/Implementing-Digital-Signatures-in-an-FDA-Regulated-Environment Stay on top of Life Sciences technologies by following us here: Blog: http://blogs.perficient.com/lifesciences Twitter: http://www.twitter.com/Perficient_LS Facebook: http://www.facebook.com/Perficient LinkedIn: http://www.linkedin.com/company/165444 Google+: https://plus.google.com/+Perficient SlideShare: http://www.slideshare.net/PerficientInc
https://wn.com/Implementing_Digital_Signatures_In_An_Fda_Regulated_Environment
FDA Vaping Regulations: HARDTALK

FDA Vaping Regulations: HARDTALK

  • Order:
  • Duration: 4:33
  • Updated: 25 Apr 2017
  • views: 2164
videos
Excerpts from a Spanish talk-show🔼 on FDA deeming regulations for e-cigarettes. CONNECT WITH ME THRU: 1) Facebook: https://www.facebook.com/qorax.stan 2) ECF: https://www.e-cigarette-forum.com/forum/members/qorax.124295/ MUSIC CREDITS: 1) Don - The Theme, by Darrel Mascarenhas 2) Don - Exclusive, by Instrumental Gravity 3) Various* by Kevin MacLeod, via Incompetech *Various sound clips of Kevin MacLeod (incompetech.com) Licensed under Creative Commons: By Attribution 3.0 License http://creativecommons.org/licenses/by/3.0/ --------------------------------------------------------------------------- COPYRIGHT DISCLAIMER: "Under Section 107 of the Copyright Act 1976, allowance is made for "fair use" of some external content/s in this video, as listed above. This is for purposes such as criticism, comment, news reporting, teaching, research etc. entailed as "fair use" by copyright statute. If owners of some of the content/s feel infringed pls contact me via PM here. Thank you." --------------------------------------------------------------------------- ****************************************************** ALWAYS REMEMBER: Vaping is a Healthier Alternative. And we have the Right to Make that Choice© ****************************************************** 🔼This is a parody folks. The subtitles are replaced to suit my content.
https://wn.com/Fda_Vaping_Regulations_Hardtalk
FDA: Limit BPA Consumption

FDA: Limit BPA Consumption

  • Order:
  • Duration: 3:07
  • Updated: 18 Jan 2010
  • views: 2517
videos
The Food and Drug Administration is now warning to limit BPA consumption, a common chemical in canned foods. As Kelly Wallace reports, BPA is normally not labeled on products.
https://wn.com/Fda_Limit_Bpa_Consumption
OUTBREAK 2016! FDA RELEASES GMO MOSQUITOES!!

OUTBREAK 2016! FDA RELEASES GMO MOSQUITOES!!

  • Order:
  • Duration: 7:41
  • Updated: 05 Aug 2016
  • views: 6199
videos
FOOLED, BAMBOOZLED, SPRAYED AND NOW HERE COME THE GMO MOSQUITOES NEVER BEFORE RELEASED IN THE U.S.(OVERTLY THAT IS) RFB http://www.the-news-daily.com/_601738 NEWS DAILY http://www.sun-sentinel.com/health/fl... SUN SENTINEL http://abcnews.go.com/Health/fda-gmo-... ABC/FDA APPROVES!!! Disclaimer: All works by RichieFromBoston are criticism, comment, news reporting, teaching and research. -All footage taken falls under ''fair use'' of the Digital Millennium Copyright Act (1998). Therefore, no breach of privacy or copyright has been committed. -FAIR USE STATEMENT This video may contain copyrighted material the use of which has not been specifically authorized by the copyright owner. This material is being made available within this transformative or derivative work for the purpose of education, commentary and criticism, is being distributed without profit, and is believed to be "fair use" in accordance with Title 17 U.S.C. Section 107
https://wn.com/Outbreak_2016_Fda_Releases_Gmo_Mosquitoes
FDA Panel Rejects Gouty Arthritis Drug

FDA Panel Rejects Gouty Arthritis Drug

  • Order:
  • Duration: 3:29
  • Updated: 22 Jun 2011
  • views: 470
videos
Safety concerns, not treatment effectiveness, prompted the Food and Drug Administration's Arthritis Advisory Committee to vote 11-1 that the data on canakinumab did not support the biologic's approval as a treatment for gouty arthritis attacks in patients who have not responded adequately to nonsteroidal anti-inflammatory drugs or colchicine. See the related story at http://tinyurl.com/5ururvb
https://wn.com/Fda_Panel_Rejects_Gouty_Arthritis_Drug
How the FDA Supports Big Food Companies in Selling More Junk Food - Dr. Rob Verkerk

How the FDA Supports Big Food Companies in Selling More Junk Food - Dr. Rob Verkerk

  • Order:
  • Duration: 5:13
  • Updated: 25 Feb 2016
  • views: 6253
videos
Visit our website: http://www.thetruthaboutcancer.com/ Join TTAC's 500K+ FB fans: https://www.facebook.com/thetruthabou... Support our mission by commenting and sharing with your friends and family below. ---------------- Summary ---------------- In this video, cancer researcher Ty Bollinger (off camera) speaks with Dr. Robert Verkerk, PhD, Executive Director of Alliance for Natural Health-International. Dr. Verkerk shares how the food policies of the FDA and the European Commission benefit big food companies. The full interview with Dr. Verkerk is part of "The Quest For The Cures Continues" docu-series. -------------------------------------------------- About The Truth About Cancer -------------------------------------------------- The Truth About Cancer’s mission is to inform, educate, and eradicate the pandemic of cancer in our modern world. Every single day, tens of thousands of people just like you are curing cancer (and/or preventing it) from destroying their bodies. It’s time to take matters into your own hands and educate yourself on real cancer prevention and treatments. It could save your life or the life of someone you love. ---------------------------------------------------------------------- Inside The Truth About Cancer Docu-Series --------------------------------------------------------------------- Doctors, researchers, experts, and survivors show you exactly how to prevent and treat cancer in our 3 original docu-series: "The Quest For The Cures”, “The Quest For The Cures Continues”, “The Truth About Cancer: A Global Quest”, and on our website: http://www.thetruthaboutcancer.com In our docu-series you’ll travel with Ty Bollinger who lost both his mother and father to cancer (as well as 5 other family members). Ty travels the country and the globe and sits down with the foremost doctors, researchers, experts, and cancer conquerers to find out their proven methods for preventing and treating cancer. Please join our email list to be notified of all upcoming events (including free airings of our docu-series): http://thetruthaboutcancer.com Learn more about our latest docu-series “The Truth About Cancer: A Global Quest” here: https://go2.thetruthaboutcancer.com/g... ------------- About Ty ------------- Ty Bollinger is a devoted husband, father, a best-selling author, and a Christian. He is also a licensed CPA, health freedom advocate, cancer researcher, former competitive bodybuilder, and author of the best-selling book "Cancer - Step Outside the Box," which has sold over 100,000 copies worldwide. After losing his mother and father and several family members to cancer, Ty’s heartbreak and grief coupled with his firm belief that chemotherapy, radiation, and surgery were the NOT the most effective treatments available for cancer patients led him on a path of discovery. He began a quest to learn everything he possibly could about alternative cancer treatments and the medical industry. What he uncovered was shocking. On his journey, he’s interviewed cutting-edge scientists, leading alternative doctors, and groundbreaking researchers to learn about hidden alternative cancer treatments. What he uncovered help to create The Truth About Cancer and its 3 awe-inspiring docu-series’:”The Quest for The Cures”, “The Quest For The Cures Continues”, and “The Truth About Cancer: A Global Quest.” Ty has touched the hearts and changed the lives of thousands of people around the world. Ty speaks frequently at conferences, local health group meetings, churches, and is a regular guest on multiple radio and TV shows and writes for numerous magazines and websites. ----------------------------------- Dr. Robert Verkerk, Alliance for Natural Health-International, ANI International, The Quest For The Cures, Ty Bollinger, The Truth About Cancer, A Global Quest, cancer (disease or medical condition), big food, bigfood, big food companies, Codex Alimentarius, junk food, unhealthy food, junk foods, effects of junk food, junk food effects, junk food kids, junk food and health, eating junk food, junk food in schools, junk food facts, fast food facts, harmful effects of junk food, about junk food, anti cancer diet, anti-cancer diet, foods that fight cancer, cancer fighting foods, cancer nutrition and healing, cancer nutrition, cancer and nutrition, cancer and sugar, beating cancer with nutrition, cancer diet, nutrition, effect of nutrition on health, nutrition and health, you are what you eat, toxins, processed food, GMOs, genetically modified foods
https://wn.com/How_The_Fda_Supports_Big_Food_Companies_In_Selling_More_Junk_Food_Dr._Rob_Verkerk
A Brilliant Lie.

A Brilliant Lie.

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  • Duration: 4:18
  • Updated: 10 Apr 2017
  • views: 1990
videos
The deeming FDA regulations (and TPD, its counterpart in the EU) is out to ruin an otherwise productive and effective revolution – Vaping. Lobbying, manipulation and disinformation is the name of the game. It's an absurd, perverse government failure – and there's no respite in sight. PAYING TRIBUTE TO: 1) Aaron Biebert: https://www.youtube.com/watch?v=zSq9iqal2cA 2) Laura Pausini: https://www.youtube.com/watch?v=ZHVdScgUm7U&list=RDZHVdScgUm7U CONNECT WITH ME THRU: 1) Facebook: https://www.facebook.com/qorax.stan 2) ECF: https://www.e-cigarette-forum.com/forum/members/qorax.124295/ REFERENCES: 1) http://www.maciverinstitute.com/2017/03/fda-regulations-ready-to-steamroll-small-vape-shops/ 2) http://fdaregs.info/fda-deeming-regulations/timeline/ 3) https://chemular.com/blogs/news/116914820-understanding-the-fda-compliance-deadlines-for-e-liquids-and-e-cigs 4) https://www.e-cigarette-forum.com/forum/forums/fda-regulations.843/ 5) http://www.stopthevapeban.com/ 6) https://en.wikipedia.org/wiki/List_of_vaping_bans_in_the_United_States 7) http://www.valuewalk.com/2017/02/ban-vaping/ 8) http://www.cstoredecisions.com/2017/02/15/e-tobacco-whats-next/ 9) Sign the petition: https://www.change.org/p/u-s-senate-u-s-house-of-representatives-president-of-the-united-states-reject-the-fda-s-deeming-of-vapor-products-as-tobacco-products-2?utm_medium=email&utm_source=notification&utm_campaign=petition_signer_receipt&share_context=signature_receipt&recruiter=10148066 MUSIC CREDIT: Non c'è - By Laura Pausini CLIP CREDITS: 1) https://www.youtube.com/watch?v=fgK_jDmGRrU 2) https://www.youtube.com/watch?v=O11IyOp7vQ0 3) https://www.youtube.com/watch?v=iMofqm6f7YE 4) https://www.youtube.com/watch?v=2U-MjMdQJc0 *Various sound clips of Kevin MacLeod (incompetech.com) Licensed under Creative Commons: By Attribution 3.0 License http://creativecommons.org/licenses/by/3.0/ --------------------------------------------------------------------------- COPYRIGHT DISCLAIMER: "Under Section 107 of the Copyright Act 1976, allowance is made for "fair use" of some external content/s in this video, as listed above. This is for purposes such as criticism, comment, news reporting, teaching, research etc. entailed as "fair use" by copyright statute. If owners of some of the content/s feel infringed pls contact me via PM here. Thank you." --------------------------------------------------------------------------- ****************************************************** ALWAYS REMEMBER: Vaping is a Healthier Alternative. And we have the Right to Make that Choice© ******************************************************
https://wn.com/A_Brilliant_Lie.
10 Weird SCHOOL RULES from Around the World

10 Weird SCHOOL RULES from Around the World

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  • Duration: 6:04
  • Updated: 04 Oct 2016
  • views: 3009922
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top 10 rules students need to follow from schools in other countries Subscribe to our channel: http://goo.gl/9CwQhg For copyright matters please contact us at: david.f@valnetinc.com Description: In order for a school to function properly, rules have to be set into motion. Otherwise, total anarchy and chaos could ensue. Most rules are pretty simple as they revolve around the concept of respect in terms of respecting the teacher and students respecting each other so that there can be a productive learning environment. However, there are some schools that want to exercise more control, and they start to break the boundaries of personal space and living realistically. Some of these rules include unbalanced dress codes where girls have to cover as much of their body as possible while boys aren’t under the same restrictions. Some of these rules even involve food, which do make sense in a way due to food allergies. However, food restrictions have taken such a bizarre turn that parents are having a hard time meeting the demands. In this video are ten unbelievable school rules from around the world. It is important to know that other countries have rules and standards that may seem weird to others. But some of these rules are just downright crazy and could very much violate the right to live as a human. The world is slowly changing and evolving to be more realistic in their school rules, but there have to be bumps in order for change to happen in some way. Whether or not these rules actually help students focus more on education, only time will tell. There are other ways to educate kids without crazy school rules, and trial and error will pave the way to that time. Our Social Media: Facebook: https://www.facebook.com/TheRichest.org Twitter: https://twitter.com/TheRichest_Com Instagram: http://instagram.com/therichest For more videos and articles visit: http://www.therichest.com/
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Medical Device Supplier Qualification and Management

Medical Device Supplier Qualification and Management

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  • Duration: 3:48:34
  • Updated: 10 Feb 2015
  • views: 547
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Medical Device Supplier Qualification and Management — Practical Approaches to Cost Effective Implementation Regulators around the globe are looking more closely at supplier management issues as device manufacturers extend their processes down the supply chain and acquire components across national boundaries. Are you ready for the increased scrutiny from FDA Investigators and Notified Bodies? You can start to prepare with important GHTF guidance documents: Control of Suppliers (GHTF/SG3/N17:2008), Risk Management Principles in a QMS (GHTF/SG3/N15R8), and Corrective Action & Preventive Action in a QMS (GHTF/SG3/N18:2010). These guidance documents provide the foundation, but lack practical details. This workshop gives you the tools and methods you need for a cost effective implementation. Attendees will learn: • The shape of the industry and current trends • The overall process and the major steps involved • Principles of risk management applied to supplier qualification and controls • The role of basic and advanced questionnaires to get the information you need • How to conduct an on-site supplier audit applying risk management • The issues presented by virtual suppliers • How to select and apply supplier metrics and their role in the QMS management review • Producing records and issues with their retention BONUS: Attendees will receive copies of implementation tools, including a process map, sample questionnaire, reevaluation form, audit checklist and more. Dan O'Leary, President, Ombu Enterprises John Avellanet, Principal Consultant, Cerulean Associates (Co-chair)
https://wn.com/Medical_Device_Supplier_Qualification_And_Management
Rexahn Receives FDA Orphan Drug Designation for RX-3117 in Treatment of Pancreatic Cancer

Rexahn Receives FDA Orphan Drug Designation for RX-3117 in Treatment of Pancreatic Cancer

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  • Duration: 2:08
  • Updated: 26 Sep 2014
  • views: 479
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ROCKVILLE, Md., Sept. 24, 2014 (GLOBE NEWSWIRE) -- Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN), a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its drug RX-3117 for the treatment of patients with pancreatic cancer. RX-3117 is a next generation, cancer-specific nucleoside analog. Rexahn is currently enrolling patients in a Phase Ib clinical trial in cancer patients and expects to complete this trial in the first quarter of 2015. The FDA's office of Orphan Drug Products grants orphan status to support development of medicines for rare disorders, defined as diseases that affect fewer than 200,000 people in the United States. Orphan drug designation provides Rexahn with certain benefits, including limited market exclusivity upon regulatory approval if received, exemption of FDA application fees and tax credits for qualified clinical trials. Preclinical studies have shown that RX-3117 maintains its anti-tumor activity in human cancer cell lines that are resistant to gemcitabine, a chemotherapy drug used to treat pancreatic cancer. Gemcitabine resistance represents a major problem in the treatment of cancer patients. In pancreatic cancer patients who have been treated with gemcitabine, up to 40% of patients became resistant to gemcitabine after 30 days. "Receiving Orphan Drug Designation for RX-3117 in the treatment of pancreatic cancer is an important milestone for this clinical development program," commented Rexahn's Chief Executive Officer Peter D. Suzdak, PhD. "RX-3117 has shown to be effective in treating cancer cells that have become gemcitabine resistant. If the results of our Phase Ib trial and future trials show similar results in gemcitabine resistant patients, this would represent a major breakthrough in the treatment of pancreatic cancer patients."
https://wn.com/Rexahn_Receives_Fda_Orphan_Drug_Designation_For_Rx_3117_In_Treatment_Of_Pancreatic_Cancer
The Mysterious Poisoned Pill Murders

The Mysterious Poisoned Pill Murders

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  • Duration: 22:15
  • Updated: 16 Sep 2017
  • views: 37090
videos
The incidents depicted happened 35 years ago. Johnson & Johnson has since introduced safety measures which have set the industry standard and established the company as a model for safety. Check out more awesome videos at BuzzFeedBlue! https://bit.ly/YTbuzzfeedvideo https://bit.ly/YTbuzzfeedblue1 https://bit.ly/YTbuzzfeedviolet GET MORE BUZZFEED: https://www.buzzfeed.com https://www.buzzfeed.com/videos https://www.youtube.com/buzzfeedvideo https://www.youtube.com/boldly https://www.youtube.com/buzzfeedblue https://www.youtube.com/buzzfeedviolet https://www.youtube.com/perolike https://www.youtube.com/ladylike BuzzFeedBlue Sports, video games, Unsolved & more epic daily videos! Credits: https://www.buzzfeed.com/bfmp/videos/30554 MUSIC Licensed via Audio Network SFX Provided By AudioBlocks (https://www.audioblocks.com) STILLS USA, Florida, Jacksonville, satellite image Stocktrek/Getty Images A John Dillinger wanted poster. John Parrot/Stocktrek Images/Getty Images Attingham Park Andreas von Einsiedel/Getty Images Front page article covering the case of 'Granny Killer' John Wayne Glover from T Fairfax Media / Contributor/Getty Images Black Binder Clips (with path) subjug/Getty Images Evidence in plastic bags Paul Taylor/Getty Images vintage map of the world 1831 javarman3/Getty Images rope string Picsfive/Getty Images Bulletin Board subjug/Getty Images pushpins ConstantinosZ/Getty Images Blank old corkboard GuidoVrola/Getty Images Lotto ticket eduardrobert/Getty Images Royalty free vector illustration Most Wanted Poster bubaone/Getty Images Classified files EXTREME-PHOTOGRAPHER/Getty Images Headlines From The Charles Stuart Shooting Boston Globe / Contributor/Getty Images Parcel wrap Nastco/Getty Images Planning notes on a napkin next to coffee edfuentesg/Getty Images Receipts DNY59/Getty Images Call me napkin grapegeek/Getty Images "Missing" and "Wanted" posters taped to brick wall RapidEye/Getty Images passport Howard Sokol/Getty Images gun for hire THEPALMER/Getty Images Secret document folder Robert Mizerek/Getty Images Vintage light bulbs choness/Getty Images Set of various paint splatters itchySan/Getty Images Finger Print Distressed ScottTalent/Getty Images Close-up of cancelled USA Uncle Sam postage stamp KingWu/Getty Images Medical Icons // Basics Valsur/Getty Images Department of Justice Building Exterior CNNARC465 Michael Rowley/Getty Images Old paper sheets, vintage photo frames and corners, open book LiliGraphie/Getty Images Signage of bar, New York, USA Wonwoo Lee/Getty Images Close-Up Of Weathered Wood On Bar Counter In Illuminated Nightclub Oliver Byunggyu Woo / EyeEm/Getty Images Pathology Department In A Hospital Stock Photo Team Static/Getty Images Television reporter interviewing policeman, USA Ken Fisher/Getty Images Crash site investigation KatarzynaBialasiewicz/Getty Images Longshoreman on dock with harbor in background Blake Little/Getty Images credit cards on dollars kizilkayaphotos/Getty Images USA Map nezezon2/Getty Images Your one stop pharmaceutical shop Yuri_Arcurs/Getty Images Train tickets icon, stock vector. Two-tone version SergeiKorolko/Getty Images Scene of the crime South_agency/Getty Images Cordoned off crime scene Yuri_Arcurs/Getty Images Furious man trying to scape from straitjacket efcarlos/Getty Images News Event related vector icons lushik/Getty Images Money and coin icon set, Vector EPS10. sumoyut/Getty Images DNA detail riccardokolp/Getty Images Older Caucasian man standing with hands in pockets Sam Diephuis/Getty Images Elderly Man Shown Holding Glasses Bettmann/Getty Images Bomb in hand Jonathan Kitchen/Getty Images Unabomber [Misc.];Hugh Campbell Scrutton [Misc.];Unabomber [Misc.] Allan Tannenbaum / Contributor/Getty Images Group of multi-ethnic business people Rawpixel/Getty Images Paper Tears Collection XXL robynmac/Getty Images Map of an urban road network phleum/Getty Images Logo of the Food and Drug Administration FDA of the USA for the food control and admittance of drugs. ullstein bild / Contributor/Getty Images Ruined Shack EduLeite/Getty Images Unabomber Let
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FDA proposes ban on trans fat in foods

FDA proposes ban on trans fat in foods

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  • Duration: 1:44
  • Updated: 07 Nov 2013
  • views: 649
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The US Food and Drug Administration has taken a bold step to remove trans fats from the food supply issuing a proposed regulation Thursday that would remove the artificially manufactured fats from its list of ingredients "generally recognized as safe." While many food manufacturers have already removed partially hydrogenated oils from their products, many still use them in sweetened baked goods, margarine, microwave popcorn, frozen pizzas, and coffee creamers. "While consumption of potentially harmful artificial trans fat has declined over the last two decades in the United States, current intake remains a significant public health concern," said FDA Commissioner Dr. Margaret Hamburg. "Further reduction in the amount of trans fat in the American diet could prevent an additional 20,000 heart attacks and 7,000 deaths from heart disease each year—a critical step in the protection of Americans' health." Trans fat is thought to be particularly heart damaging because it raises the "bad" LDL cholesterol while lowering the "good" HDL cholesterol, which raises the risk of heart disease. In a review of recent research, the Institute of Medicine determined that trans fat provides no known health benefit, and there is no safe level of consumption of artificial trans fat. The group of scientists recommended that consumers keep their consumption of trans fat as low as possible while consuming a nutritionally adequate diet. The American Heart Association applauded the FDA's proposed move calling it a "tremendous step forward in the fight against heart disease," adding in a statement that the group "has long advocated for eliminating trans fat from the nation's food supply." In a press briefing on Thursday, Hamburg said it was crucial for the food industry to provide its input on the trans fat ban during a two-month comment period in order "to determine how much time they'll need to remove partially hydrogenated oils from products." While the FDA wouldn't speculate on how long it might take to remove trans fats from foods, "six months is probably a reasonable time" to expect the industry to reformulate baked goods, said Michael Jacobson, executive director of the Center for Science in the Public Interest, a nutrition activist group in Washington DC. J.M. Smucker Company, maker of Crisco and snack foods that contain trans fats, said in a statement that it has already been working to remove partially hydrogenated oils "out of the very limited number of products" that still contain the ingredient and that they "are confident all product reformulations will be complete well before the FDA implements any new rules." Many Americans have already drastically cut their consumption of trans fats over the past decade. Boston banned trans fats in restaurants five years ago, and Brookline and Cambridge have also instituted bans. Large chains like McDonald's, Starbucks, and Dunkin Donuts also removed trans fats from their products years ago. The average American eats about 1 gram of trans fats each day compared to 4.6 grams per day in 2003. Many consumers consume some of these fats from products labeled "zero trans fats" because the FDA allows up to 0.5 grams of trans fats per serving in such products. Manufacturers will need to remove partially hydrogenated oils completely from their products in order to comply with the proposed FDA rule. "Yes, it will be difficult," said Dr. Caroline Apovian, director of the nutrition and weight management center at Boston Medical Center who worked as a paid nutrition consultant to several restaurant chains to help them remove trans fats from their menus. "But trans fats are poison, and we've known for several years now that they cause heart disease and accelerate artery plaque. The industry had ample time to figure out what to do to eliminate them." See more at: http://bo.st/192gzwe Like us on Facebook https://www.facebook.com/boston Follow us on Twitter https://twitter.com/BostonDotCom Follow us on Google+ https://plus.google.com/+BostonDotCom/posts
https://wn.com/Fda_Proposes_Ban_On_Trans_Fat_In_Foods
Precise Science - FDA

Precise Science - FDA

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  • Duration: 5:23
  • Updated: 07 Jul 2015
  • views: 345
videos
Precise Science - FDA
https://wn.com/Precise_Science_Fda
The Race To Yes FDA Ad Comm Video

The Race To Yes FDA Ad Comm Video

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  • Duration: 3:07
  • Updated: 12 May 2016
  • views: 793
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The Race to Yes Urges FDA to Use the Evidence Presented by Dozens of Scientists, Physicians, Patients and Advocates as Required by 2012 FDASIA Act for Conditional Approval Experts Remind Duchenne Community that Ad Comm Vote on accelerated approval was very close (6 yes-7 no); FDA Can Still Make Right Decision to Approve the Drug Physicians and scientists who have studied Duchenne muscular dystrophy and treated patients for decades presented compelling evidence that a new Duchenne drug, eteplirsen, works during the open public hearing section of a U.S. Food and Drug Administration (FDA) Advisory Committee Meeting (Ad Comm). They were part of an unprecedented crowd of more than 800 people imploring the FDA panel to see past rigid rules created for mass population drugs and listen to the science supporting this rare disease drug’s safety and efficacy as required by the Food Drug and Safety Innovation Act passed in 2012. “We thank the scientific community from around the globe who came to Washington DC to stand with our community and defend the science behind eteplirsen. However, we are deeply concerned that the votes at the Ad Comm displayed a lack of understanding of the science and the impact that this investigational treatment has and could have on the children who are living with this fatal disease. We encourage the FDA to honor FDASIA, and fully utilize the tools Congress has given them,” said Race to Yes co-founder Marissa Penrod of Team Joseph. “Monday’s advisory committee meeting on eteplirsen saw a unified show of support from the patients and scientists who live with, study and treat Duchenne. The testimony from Duchenne experts during the open public hearing clearly underscores the positive data generated in the small clinical trial. Scientists from Harvard, Stanford, Northwestern, Johns Hopkins and other esteemed institutions traveled from around the world to present the facts. Every single one of these scientists supports this drug’s approval,” said Race to Yes co-founder Tracy Seckler of Charley’s Fund. “On Monday, Dr. Janet Woodcock, the senior FDA official whose division is ultimately responsible for the decision, highlighted the importance of applying flexibility and considering public input in cases of fatal diseases with no treatments. She also acknowledged the grave consequence of failing to approve a drug that works. We are confident the FDA will make the right decision.” Under FDASIA, Congress gave the FDA the authority to grant accelerated approval for new treatments for life-threatening rare diseases precisely in cases like eteplirsen. Under FDASIA rules, FDA has a duty to hear and consider the evidence and knowledge available from specialized experts and the community, as well as the drug maker. It also has the flexibility to consider scientific clinical trial methods appropriate for small patient populations racing against the clock like children with Duchenne. The Race to Yes noted that the Ad Comm panel’s key vote on accelerated approval was split 6-7. Panel members were clearly constrained by the wording of the voting questions. One AdComm panelist, in reference to one of the other voting questions, went so far as to state at the meeting, “Based on all I heard, the drug definitely works, but the question was framed differently.”
https://wn.com/The_Race_To_Yes_Fda_Ad_Comm_Video
TITAN GEL FOR MEN  09954040945 / 09954040945 FDA Approve 100% no side Titan Gel Philippines

TITAN GEL FOR MEN 09954040945 / 09954040945 FDA Approve 100% no side Titan Gel Philippines

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  • Duration: 1:21
  • Updated: 23 Mar 2017
  • views: 63630
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Good Day, - - - - - P L E A S E R E A D - - - - Today we are selling Titan Gel (Tantra Gel for Men) : Special Gel for Penis. To order, PM us through our Social Network (Facebook) Page @ www.facebook.com/TitanGelPhilippines2018 and/or www.facebook.com/TitanGelOnlinePH . Just click the blue highlighted link. Send us a message with the following format on how to order: How to Order: (Please follow the Step by Step Guide below, on how to Place your Order) Step 1: Send us a Text Message for the Number of Titan Gel you want to order,complete name and address. Ex. “Hi, I would like to order 5 tubes Titan Gel, I’m Juan De La Cruz from brgy. ll Baker Street, Manila City” and Send to 09954040945 (Globe or any network) Please wait for confirmation within 1-2 hours (Usually within 5mins) we will confirm to you your total amount to pay including the shipping fee if there’s any. TITAN GEL FOR ONLY PHP 2,495 PER TUBE (Ask for 500 peso OFF for your personalized discount) Step 2: Choose a payment option. We are accepting at the following payment method: - BDO - BPI - Cebuana - Mlhuillier - Gcash - Smart Money Ask for us the instruction on how to pay. Step 3: After Sending your payment.Please send us your Order Details with the Following Format. Ex. Juan Dela Cruz,#123 Kapayapaan St. Maligaya Quezon City, 1 tube (FREE BOOKLET), P2.495.00 , Paid thru Paypal and Send to: 09954040945 (Globe or any network) or in our Facebook Page. Step 4:Wait for our Confirmation that we have received your payment, and the details of the delivery of your package.(Within the day) (cut-off time is 11:AM for First Batch and 5:00PM for Second Batch) We Dont Accept Orders For MEET-UPS. We ship our products via LBC and JRS.Your products will arrive to you in accordance with LBC, JRS Rules. (ex. 1-2 working days within Metro Manila and 1-3 working days outside Metro Manila) You can also email us @ Gmail : TItanGelPhilippines@gmail.com Thank you very much!Please feel free to contact us for inquiries and other concerns to 09954040945 (Globe or any network) or visit our Facebook Page.
https://wn.com/Titan_Gel_For_Men_09954040945_09954040945_Fda_Approve_100_No_Side_Titan_Gel_Philippines
Headlines: FDA approves device to counter heroin overdose

Headlines: FDA approves device to counter heroin overdose

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  • Duration: 1:29
  • Updated: 04 Apr 2014
  • views: 191
videos
"CBS This Morning" takes a look at some of the headlines from around the globe.
https://wn.com/Headlines_Fda_Approves_Device_To_Counter_Heroin_Overdose
Pluristem and NIAID Met With U.S. FDA and Agreed on Development Plan

Pluristem and NIAID Met With U.S. FDA and Agreed on Development Plan

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  • Duration: 2:11
  • Updated: 30 Sep 2015
  • views: 248
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HAIFA, Israel, Sept. 21, 2015 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (PSTI.TA) (PSTI.TA), a leading developer of placenta-based cell therapy products, announced today that Pluristem and the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH), completed a successful meeting with the U.S. Food and Drug Administration (FDA) regarding the development program for PLX-R18 cells in the treatment of Acute Radiation Syndrome (ARS). ARS is caused by exposure to dangerously high levels of radiation, such as those that could occur in a nuclear catastrophe. The FDA communicated that the data presented at the meeting allow for the design of large animal studies, which are the only studies required to prove efficacy for FDA approval under the Animal Rule; this is the regulatory pathway followed when human efficacy trials are not ethical or feasible. The FDA also offered to assist Pluristem with the design of these trials. The NIAID, which has supported and conducted two earlier studies of PLX-R18 in a mouse model of ARS, communicated its interest in supporting and completing trials in large animals as well, pending protocol review by the FDA. The FDA advised Pluristem to conduct a pilot study in large animals to determine the optimal dose of PLX-R18 as a treatment for the hematologic component of ARS. Once the optimal dose schedule is determined, a pivotal trial in large animals could commence. If successful, this trial would provide sufficient efficacy data for an application to the FDA for approval of PLX-R18 as a treatment for ARS. "This positive meeting with the FDA is a major step forward for our PLX-R18 program, and we expect to submit a protocol to the FDA for the dosing trial in large animals as soon as possible," said Pluristem Chair and CEO Zami Aberman. "FDA approval of PLX-R18 for ARS could generate U.S. government interest in stockpiling it for use in the case of a nuclear disaster, since PLX cell products are ideally suited for rapid initiation of treatment of large populations. Our cells do not require tissue matching prior to administration and can be administered quickly via intramuscular injection." Mr. Aberman added, "We value our close working relationship with the NIH/NIAID, and look forward to continuing to collaborate with them." Previous NIH/NIAID studies of PLX-R18 in ARS The NIH has supported and completed two mouse studies of PLX-R18 as a potential treatment of the component of ARS that affects bone marrow function. ARS involves severe, potentially lethal damage to the bone marrow's ability to produce blood cells and platelets, as well as to other systems and organs. Severe damage to bone marrow quickly makes victims vulnerable to life-threatening hemorrhage, infection and anemia. A recently concluded NIH/NIAID study showed that administration of PLX-R18 resulted in a statistically significant improvement in the recovery of white blood cell, red blood cell, and platelet levels in animals exposed to high levels of radiation, and described the cells' mechanism of action. The NIH/NIAID's first study of PLX-R18 showed a substantial, statistically significant improvement in 30-day survival and overall survival of irradiated rodents given PLX-R18 versus a control.
https://wn.com/Pluristem_And_Niaid_Met_With_U.S._Fda_And_Agreed_On_Development_Plan
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