Conference Description:

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.

Learning Objectives:

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


Areas Covered in the Webinar:

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