Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations

Duration: 90 Minutes
This webinar will provide attendees with the knowledge and skills needed to develop and produce an OTC drug product for marketing and sale in the U.S.
OTC Drug Regulations
Instructor: Loren Gelber
Product ID: 507408
Objectives of the Presentation
  • Gain a comprehensive 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
  • Recognize the difference between the various pathways for commercializing an OTC drug product
  • Understand how to identify and successfully navigate an OTC Drug Monograph
  • Recognize when reliance on a Proposed Rule, Final Rule and/or Drug Monograph is appropriate
  • Understand how to determine whether an Ingredient is considered Safe or GRAS/E for use in an OTC drug and understand the difference between Category I, II and II Ingredient designations
  • Identify the required elements of a compliant OTC Drug Label
  • Take away strategies for marketing and promoting OTC drug products, and for mitigating potential enforcement risks
  • Possess a working knowledge of the Rx-to-OTC Switch Process
  • Review and evaluate several of FDA's current OTC Monographs
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
  • 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
Who will Benefit
  • Regulatory affairs managers, directors and associates
  • Compliance specialists
  • Marketing managers
  • Quality professionals
  • Document control specialists
  • Record retention specialists
  • Senior Managers / Business Owners
  • Product Managers
  • Labeling and Artwork Designers
  • Regulatory and Quality Professionals
  • Sales and Marketing Managers
  • R&D Managers and Staff
Topic Background
The Food and Drug Administration and the Consumer Product Safety Commission have regulations pertaining to OTC drugs. The U.S. Food and Drug Administration's (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.
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Live Session - How it works
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  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Dr. Loren Gelber is currently an independent consultant, based in Charlotte, NC.She previously was employed by Akesis, Bestsweet, RRI, Andrx, Royce, Universal Research, Danbury Pharmacal, Barr and the US FDA. She has been in Regulatory Compliance, Regulatory Affairs, Clinical Research and Quality Control Laboratories.

Dr. Gelber has a Ph.D. in Medicinal Chemistry from Northeastern University, a Masters in Chemistry from Brooklyn Polytechnic and a Bachelors in Biology from Brandeis University.
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