ANDA Reviews Bogged Down By Missing, Buried Compliance Data: FDA Officials

Generic-drug makers are contributing to review delays because, intentionally or not, their ANDAs too often fail to provide a full list of personnel and facilities involved in drug manufacturing and testing, FDA officials say. The FDA has been requesting a complete picture of drug-handling data for at least the last 30 years but companies still aren’t providing it, Karen Bernard, a reviewer with the agency’s Office of Generic Drugs (OGD), said.
Drug Industry Daily