IPEC-Americas recommended to FDA at the public meeting on its quality metrics initiative and recently released draft guidance held in late August that the agency should finalize the guidance and
resolve the outstanding questions for drug products and drug substances before considering applying quality metrics to excipients. IPEC-Americas was among several industry associations that took
FDA up on its invitation to provide initial feedback at the meeting, which was held at FDA's White Oak, Maryland, headquarters on Aug. 24.
