FDA achievements overlooked by critics

It's "tremendously unfair" yet in court it's an effective criticism of the FDA that it is undermanned and sometimes comes up short of fulfilling its mission. But "the amazing thing is how well FDA responds to the challenge" of being asked to do more with less money, writes Jim Beck in The Drug and Device Law blog. The agency faces globalization of food and drug regulation and is seeking harmonization with regulators around the world; it's also scrutinizing importers and moving to risk-based inspections and enforcement. Blog


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.