Unveiling the Regulatory Landscape of OTC (Over-the-Counter) Drugs
- Understanding the concept of “OTC” (OTC-ness)
- Examining the OTC Review and monographs
- Differences between approved and monographed OTC drug products
- OTC Monograph Drug User Fee Program (OMUFA)
- FDA’s Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use
- Understanding How FDARA and the 21st Century Cures Act are impacting drug approvals through new evidentiary requirements