FDA cites clean­ing, main­te­nance is­sues at Catal­ent fa­cil­i­ty re­spon­si­ble for Re­gen­eron’s drug re­jec­tion

The FDA iden­ti­fied is­sues with main­te­nance and clean­ing at a Catal­ent man­u­fac­tur­ing fa­cil­i­ty re­spon­si­ble for the FDA re­jec­tion of a new ver­sion of Re­gen­eron’s block­buster …

Sign up to read this article for free.

Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER