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13/03/2024 14/03/2024 America/Toronto FDA Boot Camp FDA Boot Camp
March 13 – 14, 2024
SpringHill Suites NY Manhattan Times Square South, New York, NY
Please visit https://www.americanconference.com/fda-boot-camp/ for more information and updates. SpringHill Suites NY Manhattan Times Square South, New York, NY true DD/MM/YYYY 1440 use-title -
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13/03/2024 14/03/2024 America/Toronto FDA Boot Camp FDA Boot Camp
March 13 – 14, 2024
SpringHill Suites NY Manhattan Times Square South, New York, NY
Please visit https://www.americanconference.com/fda-boot-camp/ for more information and updates. SpringHill Suites NY Manhattan Times Square South, New York, NY true DD/MM/YYYY 1440 use-title -
Unveiling the Regulatory Landscape of OTC (Over-the-Counter) Drugs
Samantha Hong
Partner
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