OTC Drug FDA Regulation

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Webinar Includes : All the training handouts , Certificate ,Q/A and 90 Min Live Webinar

"Listen from Dr. Loren Gelber has worked in the pharmaceutical industry for more than 40 years, at both the FDA and in private industry."

Rx-to-OTC Switch Process.


The FDA and the Consumer Product Safety Commission have regulations pertaining to OTC drugs. The FDA is responsible for the regulation and oversight of the U.S. OTC drug market. Congress has granted FDA regulatory authority over the formulation, manufacturing, labeling, marketing and promotion; and import / export of OTC drug products into the U.S. Under this current regulatory regime, there are 4 pathways that a company may follow to enter the OTC drug market including (a) following an appropriate Drug Monograph; (b) with an Agency approved New Drug Application (“NDA”); (c) via the currently popular Rx-to-OTC Switch Process or (d) via an ANDA citing a previously-approved product.

This webinar will discuss U.S. Food and Drug Administration (FDA) and Consumer Product Safety Commission regulation of OTC drug products and mitigating the risk of enforcement action in the future. Attendees will gain an understanding of various available strategies for producing and selling an OTC drug and the definition of OTC products

Areas Covered

•        Gain an understanding of how OTC drug products are regulated in the U.S.
•        Learn to distinguish between a potential Rx pharmaceutical product and an OTC drug.
•        Understand the difference between the various pathways for commercializing an OTC drug product.
•        Learn how to identify and successfully navigate an OTC Drug Monograph.
•        Know when reliance on a Proposed Rule, Final Rule and/or Drug Monograph is appropriate.
•        Know the required elements of a compliant OTC Drug Label.
•        Understand strategies for marketing and promoting OTC drug products, and for mitigating potential enforcement risks.
•        Learn the Rx-to-OTC Switch Process.
•        Review and evaluate several of FDA’s current OTC Monographs and Warning Letters 

Who will Benefit

•          Regulatory affairs managers, directors and associates
•          Compliance specialists
•          Marketing managers
•          Quality professionals
•          Document control specialists
•          Record retention specialists

Industries who can attend

This 90-minute online course is intended for professionals in the Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Speaker Profile

Dr. Loren Gelber

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 requirements. She has a BA in Biology, an MS in Chemistry and a Ph.D. in Medicinal Chemistry.

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