Unveiling the Regulatory Landscape of OTC (Over-the-Counter) Drugs

March 13, 2024 12:45pm

Samantha Hong
Kleinfeld, Kaplan & Becker LLP

  • 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