Hurricane Sandy blows back drug apps at the FDA

Some regulatory teams in the biopharma industry may be left on tenterhooks as they go into overtime waiting for official word on their drug applications. Hurricane Sandy put a crimp in the FDA's schedule. The agency--closed on the 29th and 30th of October--says it may have to tap the brakes on some drug and device applications, with a two-day delay on some drug and device decisions due after October 31. Story


Suggested Articles

Solid Bio fixed the manufacturing issue that led to a partial clinical hold on its DMD trial, but a full hold remains.

Commissioner Scott Gottlieb has laid out the reasons why he thinks the FDA needs a double-digit budget bump.

GW's cannabis-based epilepsy drug scored a favorable review from FDA staff ahead of an expert panel meeting.