FDA Dispute Resolution Process Should Be Less Structured, Merck Exec Says
This article was originally published in The Pink Sheet Daily
FDA should extend the deadline to challenge inspection findings and allow feedback for further clarification after a firm submits its response, Merck's Haggard says. The agency plans to share case studies of GMP issues to prevent future disputes.
You may also be interested in...
The initiative to develop risk-based oversight of drug manufacturing will enter a new, less frenetic phase at its two-year anniversary in August. The project is a carryover from Deputy Commissioner Crawford's first term as acting head of FDA.
Amended application includes 50 mg and 100 mg dosage forms, which are used in multiple myeloma.