If you’re new to the OTC field or need a refresher on the fundamentals, this webinar will focus on the legal and regulatory world of OTCs from an introductory perspective. You’ll learn about labeling and marketing regulations; navigate through the various FDA guidances available to assist you; understand the pathway for taking an OTC drug to market; learn strategies for avoiding risks based on recent FDA enforcement actions; and see how each of these areas comes alive through case studies.

Seminar Information
Seminar Date:
September 20, 2012
Webinar Objectives
  • Learn how to practically apply OTC statutes and regulations in the real world
  • Understand the regulatory bodies that govern OTCs and where to find their applicable and necessary guidances
  • Learn how to avoid regulatory challenges through case studies
  • Explore the various methods to take an OTC drug to market (New Drug Applications, Monograph or Rx-to-OTC switch) and the benefits/risks of each method
  • Identify rules for labeling and marketing an OTC drug through case studies
Inside OTCs: Legal and Regulatory 101
Speaker Information
Doug Bierer Ph.D.  [ view bio ]
Gerald Masoudi Esq.
David Spangler (Moderator)  [ view bio ]
Individual topic purchase: Selected
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CHPA Member Price:$199.00
Non-Member Price:$199.00