FDA's Regulation of Over-the-Counter (OTC) Drugs Monographs and NDAs for Safety and Efficacy Goals

Duration 75 Mins
Level Basic
Webinar ID IQW19K1170

  • Rx versus OTC Drugs – Deciding which classification
  • How are OTC drugs regulated?
  • Labeling Rules
  • CGMPs
  • Avoiding FDA Warning Letters

Overview of the webinar

The three ways that the FDA regulates OTC (Over-the-Counter) drugs: Monographs, Rx to OTC switches and NDA/ANDA submissions, will be discussed in detail. Labeling and advertising of OTC drugs will be covered. Other requirements, including Registration, Drug Listing and Current Good Manufacturing Practice will be reviewed. Examples from recent Warning Letters and FDA Inspectional Observations (483s) will be used to show what not to do.

Who should attend?

  • Regulatory Affairs Professionals
  • OTC product selectors
  • Labeling Experts
  • Quality Experts
  • Advertising of OTC Drugs
  • Pharmaceutical Executives
  • Pharmaceutical Research and Development
  • Pharmaceutical Regulatory Affairs
  • Regulatory Compliance Officer

Why should you attend?

Both new and experiences OTC manufacturers will benefit from a review of the various FDA rules for OTC drugs. Knowledge of these rules and regulations are important for staying out of trouble with the FDA, which should be one of the main objectives of every drug manufacturer.

Faculty - Dr. Loren Gelber

Dr. Loren Gelber has more than 40 years in the pharmaceutical industry. She spent her first ten years at FDA, followed by 20 years in Regulatory Affairs and Compliance at various pharmaceutical companies, and the last ten years as a Regulatory Compliance Consultant. During this time she was a member of various groups and committees that worked on many compliance issues. She has published a number of papers and delivered various seminars and talks. Dr. Gelber holds a BA in Biology from Brandeis University, an MS in Chemistry from Brooklyn Polytechnic Institute (now part of NYU) and a PhD in Medicinal Chemistry from Northeastern University School of Pharmacy and Allied Health Professions. She current resides in Charlotte, NC.

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