J&J Bedaquline and the Evolving Role for Accelerated Approval: Confirming Safety, Not Efficacy?

December 4, 2012. FDA Beat. Discussions during an advisory committee review Janssen’s TB drug bedaquiline showed some interesting thinking around accelerated approval and how much uncertainty can be acceptable—especially when it comes to safety. Yttri warned called “approval of drugs based on the promise of benefit” a “dangerous practice.” Continue reading

Allergan drops bid for FDA approval to promote Lap-Band for teens

October 3, 2012. LA Times. The maker of the Lap-Band weight-loss device, Allergan Inc., has dropped its controversial bid for federal approval to market the product for overweight teens. Doctors already can perform Lap-Band surgery on minors with parental consent. The FDA approval would have allowed Allergan to market Lap-Band specifically for younger people. Continue reading