FDA Regulation of Over-the-Counter (OTC) Drugs webinar

  • Instructor : Dr. Loren Gelber
  • Level : Intermediate
  • Study time : 61 minutes
  • Course ID: TF2950
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ABOUT THE COURSE

Are you confident your OTC products follow the right FDA regulatory pathway?
Do you know when an NDA, ANDA, or monograph applies to your product?
Could your team be making labeling or GMP mistakes that risk a 483 or Warning Letter?


This training cuts through the complexity of OTC drug regulation—from Rx switches to monographs to GMPs—so you stay compliant, market faster, and avoid costly mistakes.


WHAT WILL YOU GAIN
  • A complete understanding of how FDA classifies and regulates OTC drugs
  • Clarity on when NDAs, ANDAs, or monographs apply—and what to do next
  • Actionable insights from recent FDA enforcement cases and labeling missteps


WHY TAKE THIS COURSE
  • Protect your brand by avoiding preventable regulatory pitfalls
  • Get every department aligned on the right compliance framework
  • Use real examples to strengthen your labeling, filing, and GMP practices


KEY AREAS COVERED
  • Definitions and distinctions between Rx and OTC drugs
  • Three FDA pathways for regulating OTC products
  • When to file NDA or ANDA vs. follow an OTC monograph
  • Labeling requirements specific to OTC drug products
  • Registration, listing, and GMP obligations for manufacturers
  • FDA 483s and Warning Letters—recent real-world examples

Quality training, expert insights, and answers that matter. Know your Expert

Dr. LOREN GELBER

Dr. Loren Gelber brings over four decades of regulatory wisdom—spanning her work at the FDA and leadership roles in major pharmaceutical companies. She’s reviewed generics, consulted across industry, and helped countless teams make sense of complex rules. If your team works on OTC products, Dr. Gelber is the voice of clarity you want on your side.

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