Baxter clears violations from clogged filter warning letter

Baxter has resolved manufacturing issues cited in an FDA warning letter concerning clogged filters at a plant in Belgium, where it makes immune-system treatment Gammagard. Issues concerned how the company investigated and handled the matter. Closeout letter | Warning letter


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

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

Learn how 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.