FDA Action on Antiseptic Wash Products: What is Next for the Industry?

Duration: 60 Minutes
The FDA just banned 19 active ingredients that are used in antibacterial soaps. This major regulation will have a huge impact on this multi-million-dollar industry since the FDA Rule will require companies to remove these ingredients from their products or remove the products from the market. Manufacturers will have one year to take these products off the market or reformulate them. This presentation will cover FDA Action on Antiseptic Wash Products and what is next for the Industry.
FDA Action on Antiseptic Wash Products
Instructor: Norma Skolnik
Product ID: 501903
Objectives of the Presentation
  • To learn about FDA's reasons for banning certain ingredients in antiseptic/antibacterial soap products
  • To identify the 19 ingredients that FDA banned from use in antiseptic soaps
  • To understand why FDA deferred rulemaking for other ingredients
  • To understand timelines for FDA compliance with their Final Rule
  • To learn which products are not affected by the final rule and usage requirements
  • To hear about the industry response to FDA's actions and what the future may hold
Why Should you Attend
Attending this presentation will give one a better understanding of why FDA took this action regarding Antiseptic Wash products and how these major changes are being implemented as well as implications for the future of these products.

Areas Covered
  • FDA reasons for banning certain ingredients in antiseptic/antibacterial soap products
  • 19 ingredients that FDA says can no longer be marketed in antiseptic soaps
  • Ingredients for which FDA has deferred rulemaking to allow for development and submission of new safety and effectiveness data
  • Timelines for compliance with FDA's final rule
  • Products not affected by the final rule and usage requirements
  • Industry response to FDA's actions on Antiseptic Soaps
Who will Benefit
  • Regulatory managers
  • Regulatory associates
  • Antiseptic product marketing managers
  • QA Managers
$375
Recorded Session for one participant
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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
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.
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