Objectives of the Presentation
- Learn why OTC & Prescription drug and dietary supplement companies get FDA warning letters
- Learn about FDA enforcement priorities for drugs & dietary supplements
- Review examples of FDA warning letters that drug & dietary supplement companies have received
- Get tips on why drug & dietary supplement firms get warning letters due to illegal label claims and advertising & promotional issues
- Get helpful tips on how to avoid warning letters and respond to an FDA Warning Letter if you do receive one
- Proactive and Reactive Strategies for Communicating with FDA
This training will focus on why Rx, OTC drug and dietary supplement companies receive FDA warning letters primarily due to claim issues and what steps can be taken to avoid them. Along with examples of warning letters, you will be provided with tips and strategies for communicating with the FDA and how to respond to a warning letter. You will be given the references to all relevant FDA & FTC regulations and guidance documents.
Regulatory Consultant ,
EAS Consulting Group & NS Consulting
Norma Skolnik works as a regulatory consultant to FDA regulated companies and to firms who wish to launch products in the U.S.A. Norma has over 35 years of U.S. regulatory experience, starting in the pharmaceutical industry. She was the 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 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.
- Regulatory Affairs managers, directors & Associates, Product safety managers, Compliance Specialist
- Regulatory affairs professionals
- Senior management executives (CEO, COO, CFO, etc)
- Dietary supplement manufacturers, marketers
- Regulatory compliance associates and managers
- Legal and medical experts involved in dietary supplements industry
- People investing in FDA-regulated product development projects
- Packaging Personnel & Management
- Design Personnel & Management
- Quality Assurance Analyst & Management
- Marketing and Product managers
- Drug & Dietary Supplement company attorneys