Anyone who markets drug or dietary supplement products in the USA should be aware of the seriousness of an FDA Warning Letter and know how best to avoid receiving one.
This webinar will provide recent examples of FDA Warning letters to convey an understanding of why companies receive them. Proactive and reactive strategies for responding to FDA Warning letters will be covered in this webinar.
Learning Objectives:
- 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
Why Should You Attend:
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.
Topics
- In 1994, the Dietary Supplement Health and Education Act (DSHEA) defined dietary supplements as a category of food, which put them under different regulations than drugs. They are considered safe until proven otherwise. The DSHEA says that dietary supplements cannot contain anything that may have "a significant or unreasonable risk of illness or injury" when the supplement is used as directed on the label, or with normal use if there are no directions on the label.
- A dietary supplement is considered "new" if it contains an ingredient not recognized as a food substance, unless it was sold as a supplement before October 1994. If it is new, the manufacturer must provide the FDA with reasonable evidence that the new ingredient is safe before the supplement is marketed to the public.
- A nonprescription, or over-the-counter (OTC) medicine, is a drug that the U.S. FDA has found to be safe and effective for direct consumer use based on the label instructions and warnings and compliance with OTC drug regulations. FDA requires a wider margin of safety for OTC medicines than for prescription drugs.
Instructor
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, when Pfizer acquired 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.