Tomorrow: Issues and Case Studies in Clinical Trial Data Sharing
By The Petrie-Flom Center
FDA
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Read more: Tomorrow: Issues and Case Studies in Clinical Trial Data Sharing -
Read more: Labeling GMO Food Labeling GMO Food
Check out this recent Bloomberg piece from Cass Sunstein: Don’t Mandate Labeling for Gene-Altered Foods. He raises a number of arguments that came out during the Q&A following our recent conference panel on food regulation. Video should be posted soon!
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Read more: Upcoming Conference: Issues and Case Studies in Clinical Trial Data Sharing Upcoming Conference: Issues and Case Studies in Clinical Trial Data Sharing
By The Petrie-Flom Center
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Read more: Live Blogging FDA in the 21st Century Conference, Panel 9 – Addressing the Challenges of and Harnessing New Technologies Live Blogging FDA in the 21st Century Conference, Panel 9 – Addressing the Challenges of and Harnessing New Technologies
By Holly Fernandez Lynch Last but not least! Our final conference panel focused on “Addressing the Challenges of and Harnessing New Technologies,” and was moderated by Fran Miller. We heard first from Margaret Riley on “Twenty-First Century Technology with Twentieth Century Baggage: FDA Regulation of Regenerative Medicine.” Riley explained that regenerative medicine (i.e., the use…
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Read more: Live Blogging from FDA in the 21st Century Conference, Panel 8: Food, Supplement, and Tobacco Regulation Live Blogging from FDA in the 21st Century Conference, Panel 8: Food, Supplement, and Tobacco Regulation
By I. Glenn Cohen [Live blogging off-the-cuff, so apologies in advance for any errors in summarizing, typos, etc] Moderated by Emily Broad Leib, Harvard Law School Robin Craig, Leslie Francis, and Erika George, University of Utah The FDA’s Authority Over Labeling: Current Ironies and Future Improvements: Goal is to look at FDA authority over safety…
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Read more: Live Blogging FDA in the 21st Century Conference, Plenary 3: Susan Winckler, President and CEO of FDLI Live Blogging FDA in the 21st Century Conference, Plenary 3: Susan Winckler, President and CEO of FDLI
[Posted on behalf of Holly Fernandez Lynch, Executive Director, Petrie-Flom Center (with the same disclaimer about the off-the-cuff nature of live blogging)] For the last plenary session of the conference, we heard from Susan Winckler, President and CEO of the Food and Drug Law Institute, who discussed “Other Influencers of Food and Drug Law” – namely the…
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Read more: Live Blogging from FDA in the 21st Century Conference, Panel 7: Major Issues in Device Regulation Live Blogging from FDA in the 21st Century Conference, Panel 7: Major Issues in Device Regulation
By Jeffrey Skopek [Posted on behalf of Jeffrey Skopek, Academic Fellow, Petrie-Flom Center (with the same disclaimer about the off-the-cuff nature of live blogging)] Jeffrey Shapiro (Hyman, Phelps, McNamara PC), Why the 510(k) Pathway is the Right Approach for Most Medical Devices Jeff Shapiro began with an introduction to FDA approval processes for medical devices. He explained that…
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Read more: Live Blogging from FDA in the 21st Century Conference, Panel 6: Regulatory Exclusivities and the Regulation of Generic Drugs and Biosimilars Live Blogging from FDA in the 21st Century Conference, Panel 6: Regulatory Exclusivities and the Regulation of Generic Drugs and Biosimilars
By W. Nicholson Price II [Posted on behalf of W. Nicholson Price II, Academic Fellow, The Petrie-Flom Center (with the disclaimer re: live blogging – see posts below)] The first panel of today is on regulatory exclusivity and generic drugs, moderated by Ben Roin at the Petrie-Flom Center. Leading off was Kate Greenwood, discussing orphan drug development…
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Read more: Live Blogging from FDA in the 21st Century Conference, Plenary 2: Alta Charo on Integrating Speed and Safety Live Blogging from FDA in the 21st Century Conference, Plenary 2: Alta Charo on Integrating Speed and Safety
By Michelle Meyer [This is off-the-cuff live blogging, so apologies for any errors, typos, etc] Day two of PFC’s FDA in the 21st Century conference begins with a morning plenary by the very fabulous Alta Charo, of the University of Wisconsin Law School, who is speaking on “Integrating Speed and Safety.” Today Alta is presenting what…
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Read more: Live Blogging from FDA in the 21st Century Conference, Panel 5: Major Issues in Drug Regulation Live Blogging from FDA in the 21st Century Conference, Panel 5: Major Issues in Drug Regulation
By I. Glenn Cohen [Live-blogging off-the-cuff, all errors, typos, etc, are my fault] Geoffrey Levitt, Pfizer, Drug Safety Communication: The Evolving Environment A drug by itself is just an object. Because of that fact it creates turf, governance. You must have effective processes for communicating accurate info. Pharmacovigilance is the accuracy part. Spontaneous adverse event…