News & Analysis as of

Medical Devices › Pharmaceutical Industry › Citizen Petitions

Epstein Becker & Green

Unpacking Averages: Analyzing FDA Device-Related Citizens Petitions by Topic

Epstein Becker & Green on

Those who have been reading this blog know that I like to analyze collections of documents at FDA to discern, using natural language processing, whether, for example, the agency takes more time to address certain topics than...more

Epstein Becker & Green

Unpacking Averages: FDA’s Extraordinary Delay in Resolving Citizen Petitions

Epstein Becker & Green on

This month I wanted to take a data-driven look at FDA’s treatment of citizen petitions, and specifically as a starting point how quickly the agency resolves those petitions.  Make no mistake, I have an interest in this...more

Mintz - Health Care Viewpoints

FDA Hardens Its Stance on Intended Use and Off-Label Use and Industry Responds

Mintz - Health Care Viewpoints on

From 2015 to 2016, FDA appeared to open the door to loosening the standards around intended use and off-label use, but recent rule-making and public comments suggest that FDA is becoming more sclerotic instead of flexible....more

3 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide