GMPs, generics and repackaging drive recalls

It's not just careless inattention to manufacturing. It turns out that drug repackaging, the generics rush and a more attentive FDA that led to "a record high 1,742 drug recalls in 2009," says Health Reform Watch. That's a jump from 426 in 2008.

Take former drug re-packager Advantage Dose, for example, which was responsible for more than 1,000 of them. The company garnered a 38-item Form 483 following a 2008 audit.

The article quotes stats from The Gold Sheet indicating also that role that generics manufacturers may play in the rocketing of recalls. They sometimes cut development costs in their rush to be first to market. So they may not take the time to learn the best way to make that drug.

The stricter drug regulatory environment, engendered in part by heightened Congressional scrutiny of the FDA, is also a contributor to the spike. The likely outcome: increased FDA regulatory power.

- here's the 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.