Conferences / Meetings

Event Categories:

  • search by keywords:

Sponsored Links


  • An Introduction to FDA's Regulation of Over-the-Counter
    (OTC) Drug Products

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Wednesday - Aug 07, 2013 10:00 AM
  • End Time:
  • Wednesday - Aug 07, 2013 11:30 AM
  • Location:
  • Online
  • This webinar will provide an introduction to the FDA’s regulation of Over-the-Counter (OTC) drug products and the various methods for bringing such a product to market.

    Why Should You Attend:

    All OTC drugs are regulated by the U.S. Food and Drug Administration’s (“FDA”) and can enter the market in one of the following ways: (a) by complying with an applicable monograph; (b) as the subject of an FDA approved New Drug Application; or (c) via an FDA approved Rx-to-OTC Switch.

    This webinar will provide beginners with an introduction to FDA’s regulation of OTC drug products. Some of the topics to be covered in this webinar include:

    - Whether a drug product can be marketed and sold as an OTC
    - The various pathways for bringing an OTC drug to market
    - The OTC Monograph process and the products currently covered by monographs
    - Switching an Rx drug product to an OTC
    - Rules for labeling and marketing an OTC drug product, and
    - Strategies for mitigating potential FDA regulatory risks based on recent - Agency enforcement action.
  • Website:
  • Visit the website for detail info

Event Guests

  • No member available


No Comments available

© 2009-2020, All Rights Reserved.
Higher Ed Space ® is a registered trademark of AmeriCareers LLC.