FDA Draws Up Blueprint for Pre-Approval Facility Reviews

The FDA has outlined plans for coordination between CDER and ORA in checking out the manufacturing facilities of drugmakers seeking approval for new pharmaceuticals.

A 20-page agency report entitled “Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations” was completed in June, but it has been thrown into high relief this month by the enactment of user-fee renewal legislation (FDARA) that includes mechanisms for speeding drug approvals.

The report describes a two-part, pre-approval process for reviewing the manufacturing facility referenced in a company’s application for approval: evaluation and inspection. Any post-approval inspections will follow the pre-approval inspection model.