Generics and FDA : delays

FDA is known to have issues with resources and people, so things get delayed often with FDA. When a generic drug maker like Ranbaxy (yes, the new indo-japanese drug company) submits a generic drug application to FDA it is supposed to take 180 days for the review to come around. During this period the application passes through three FDA divisions (thanks to the beaureacracy) and gets reviewed.

In a recent review by Health and Human services the median duration of an application review was 217 days, and 96% of the applications were rejected. Thats a problem since the economy needs generics to stay on the track. FDA cites that the common reason for rejection is poorly made drug applications.

FDA has extensive details on how generic drug applications have to be submitted, how they are reviewed : http://www.fda.gov/cder/handbook/anda.htm and regulations surrounding the new drug applications http://www.fda.gov/cder/ogd/#Laws