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OTC Drug Regulations - Webinar

  • ID: 4899691
  • Webinar
  • October 2019
  • Region: Global
  • 180 Minutes
  • Compliance Online
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Why Should You Attend:

This webinar will discuss U.S. FDA and Consumer Product Safety Commission regulation of OTC drug products and strategic recommendations for mitigating the risk of enforcement action in the future. Attendees will gain an understanding of various available options for producing and selling an OTC drug product.

FDA and CPSC requirements for OTC drugs will be covered. There will also be some discussion of the market differences between Rx and OTC products.

Areas Covered in the Webinar:

Claims for drugs, devices, medical foods and cosmetics
NDA, ANDA and OTC Monographs for OTC Drugs
Rx to OTC Switches
cGMPs for OTC drugs
Tamper Evidence and Poison Control
Branded Innovator, Branded Generic and Generics
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Dr. Loren Gelber has worked in the pharmaceutical industry for more than 40 years, at both the FDA and in private industry. She has been involved in numerous launches of OTC drugs and in Rx to OTC switches. Her specialty is compliance with US regulatory compliance. She has a BA in Biology, an MS in Chemistry and a Ph.D. in Medicinal Chemistry.
Note: Product cover images may vary from those shown
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