FDA moves a step closer to executive prosecutions

The FDA initiated 600 criminal prosecutions against companies in 1939 and it seems to be longing for the good old days. Its Office of Criminal Investigations, recently focused on fraud cases, appears ready for a shift to manufacturing as drug and device recalls grab headlines. CNN Money says the regulator has grown weary of protracted warning letter correspondence. It's studying the dusty Park Doctrine, under which it can prosecute corporate executives for manufacturing as well as other lapses. "It's going to happen. Do what you can and do the right thing before we find out about it," the story quotes an FDA official. Article

Webinar

Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.