FDA Regulation of OTC Drugs in the U.S
- Speaker:NORMA SKOLNIK
- Product Code:GRC-90346
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This webinar will cover laws and regulations for successful marketing and compliance of OTC Drugs in the USA. The presentation will provide an overview of FDA OTC Drug regulations with a focus on OTC Drug Labeling requirements. It will help the attendee understand basic regulatory requirements for marketing and labeling OTC drugs successfully in the USA.
Objectives of Topic:
- To gain an understanding of current Regulatory requirements for marketing OTC drugs in the U.S.;
- To understand what OTC drug claims & labeling comply with FDA regulations;
- To learn OTC Drug Facts labeling requirements;
- To learn about the importance of OTC Drug Monographs;
- To cover FDA serious adverse event reporting rules that are required for OTC drugs in the U.S.
Areas Covered in the Session :
- Key regulatory requirements for marketing OTC drugs in the U.S.;
- FDA labeling requirements for OTC drugs;
- What claims are appropriate for OTC drugs vs. those to avoid; Rx to OTC Switch drugs;
- FDA’s changing views on enforcement;
- Serious Adverse Event reporting for OTC drugs.
Norma Skolnik has over 35 years of U.S. regulatory experience, starting in the pharmaceutical industry. She was Associate Director of Regulatory Affairs at Lederle Laboratories in Pearl River, N.Y. and then became Associate Director of Regulatory Affairs at Lederle Consumer Health where she helped launch Centrum and Caltrate dietary supplements.
When Lederle was acquired by Wyeth, she became Associate Director of Regulatory Affairs there, acquiring more experience in the Dietary Supplement and OTC drug fields. She joined Warner-Lambert Consumer Health division in 1998 and became Assistant Director of Adams Regulatory Affairs. In 2002 after Pfizer’s takeover of Warner-Lambert, she was promoted to Director of Regulatory Affairs for the Adams division. Adams was acquired by Cadbury-Schweppes in 2003 and she served as Cadbury Adams’ Director of Regulatory Affairs for the Americas from 2003 until her retirement in 2008.
Norma earned a Bachelor’s degree in Biology from the University of Cincinnati and holds a Master’s degree from Pratt Institute in Brooklyn, New York. She's also done graduate work at Columbia University and Montclair State University. Today Norma works as a regulatory consultant to FDA regulated companies and to firms who wish to launch products in the U.S.A.