Executive Summary

"FIRST-PARTY" DRUG AUDIT PROGRAM TO BE PROPOSED BY FDA in an upcoming Federal Register notice, Center for Drug Evaluation & Research Compliance Office Director Stephanie Gray told the Pharm Tech annual conference in Philadelphia Sept. 15. The program, designed to help streamline FDA's enforcement of Good Manufacturing Practice regs for drugs, will allow companies with good quality control track records the option of submitting in-house audits to the agency in return for fewer inspections on more specific issues, Gray explained.