Monthly Archives: January 2018

Weekly Roundup 1.26.18

Posted on January 26, 2018 by Mark Senak

The funding kerfuffle came and went. Order was restored to the universe after a brief blip shuttered federal agencies, FDA among them, for a single work day.  It almost seems like a distant memory already, until next time. The weather … Continue reading →

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Is FDA Running Out of Juice on Social Media?

Posted on January 25, 2018 by Mark Senak

FDA held a public meeting in April 2009 on the regulation of promotional speech on social media by medical product manufacturers and set the framework for the discussion (and the subsequent regulation) by asking five questions. Ostensibly guidance was to … Continue reading →

Posted in New and Social Media, Social Media | 2 Comments

What They Said – FDA Press Releases 2017

Posted on January 23, 2018 by Mark Senak

Keeping our eye on FDA press releases as one measure of the way FDA talks to us is a regular feature here on Eye on FDA and there is no better time to look back than when we begin a … Continue reading →

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Weekly Roundup 1.19.18

Posted on January 19, 2018 by Mark Senak

As noted below, next week the Senate HELP Committee will hold Part 2 of a hearing series on public health threats in the 21st Century. Ironically this comes at the same time we are facing a series of deadlines to … Continue reading →

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Taking a Peek at Transparency – An FDA Pilot Program

Posted on January 17, 2018 by Mark Senak

Yesterday, Commissioner Scott Gottlieb announced a new effort on the part of the agency aimed at increasing transparency around clinical trials, a goal long sought by many patient advocates, particularly outside the U.S.  Specifically, FDA is introducing a pilot program … Continue reading →

Posted in Clinical Trials, FDA Policy | 2 Comments