FDA Pins ANDA Backlog on Inspection Resources, Calls for User Fees

The FDA is telling generic-drug makers that a lack of resources to conduct inspections outside of the U.S. is largely to blame for the agency’s backlog in ANDAs and is urging the industry to accept user fees as a solution the problem. In a speech Thursday at the Generic Pharmaceutical Association annual meeting in Orlando, Deborah Autor, director of the FDA’s Office of Compliance, told drugmakers that the agency currently has 192 foreign generic-drug manufacturing facilities requiring a pre-approval inspection but, because of its limited resources, is only scheduled to conduct 62 of those inspections in fiscal 2011.
Drug Industry Daily