Start Date: 9/29/2020 10:00 AM EDT
End Date: 9/29/2020 1:30 PM EDT
Venue Name: Virtual Event
This one-day, virtual event features expert speakers provide in-depth learning on the latest issues in the cosmetic and personal care products industry.
Don't miss two speakers from the FDA: Linda Katz, M.D., M.P.H., Director, Office of Cosmetics & Colors, Center for Food Safety and Applied Nutrition (CFSAN), FDA and Theresa M. Michele, M.D., Director, Division of Nonprescription Drug Products, Center for Drug Evaluation and Research (CDER), FDA
A ‘must attend’ for anyone responsible for developing, testing and marketing beauty, personal care and wellness products.
Members - $0.00 / Non-members - $125.00
10:00 AM | Welcome
Kenneth Marenus, PhD, President, IBA
Craig Weiss, IBA Technical/Regulatory Committee Chair
10:00 – 11:00 AM | Hand Sanitizers – Contaminant Testing & Legal Implications
Sharon Blinkoff, Counsel, Locke Lord LLP; Craig Weiss, President, Consumer Products Testing Company
11:00 AM – Noon | Current U.S. FDA Cosmetics Developments
Linda Katz, M.D., M.P.H., Director, Office of Cosmetics & Colors, Center for Food Safety and Applied Nutrition (CFSAN), FDA
Dr. Linda M. Katz is the Director of the Office of Cosmetics and Colors (OCAC), in the Center for Food Safety and Applied Nutrition (CFSAN) at the Food and Drug Administration (FDA), which regulates cosmetics and certifies colors used in foods, cosmetics, drugs, and devices. Dr. Katz joined the FDA in 1989 in the Center for Drug Evaluation and Research (CDER) first as a primary medical officer and later as Team Leader and Acting Director of the Pilot Drug Evaluation Staff, which reviewed anti-rheumatic drugs, anesthetic agents and drugs of abuse. Her subsequent appointments included: Deputy Director of the Division of Dermatologic and Dental Drug Products and Deputy Director of the Division of Over-the-Counter Drug Products. In 2002, Dr. Katz joined CFSAN in her present position and additionally served 10 years as the Acting Chief Medical Officer. Dr. Katz received her MD from the University of Connecticut School of Medicine, her MPH in Epidemiology from the University of Michigan School of Public Health, and her BA in Biology from the University of Pennsylvania. She did her internship and residency in Internal Medicine and fellowship in Rheumatology at the George Washington Medical Center. In addition, Dr. Katz has taught at Walter Reed Army Medical Center and has numerous publications in the scientific and medical literature.
Noon – 1:00 PM | OTC Drug Monograph Reform
Theresa M. Michele, M.D., Director, Division of Nonprescription Drug Products, Center for Drug Evaluation and Research (CDER), FDA
On Friday, March 27, 2020, the President signed the Coronavirus Aid, Relief, and Economic Security Act (CARES Act)
to aid response efforts and ease the economic impact of COVID-19. In addition to the COVID-19 response efforts, the CARES Act includes statutory provisions that reform and modernize the way OTC monograph drugs are regulated in the United States. Specifically, the CARES Act replaces the rulemaking process with an administrative order process for issuing, revising, and amending OTC monographs. The CARES Act also provides FDA the authority to assess and collect user fees dedicated to OTC monograph drug activities. This presentation will provide a high level overview of OTC monograph reform provisions under the CARES Act.
Dr. Theresa Michele
is currently the Director of the Office of Nonprescription Drugs (ONPD) in the Office of New Drugs, Center of Drug Evaluation and Research (CDER), at the Food and Drug Administration (FDA). Prior to joining FDA in the Division of Pulmonary and Allergy Drug Products, she spent 10 years in industry, with clinical research experience across a variety of therapeutic areas in both commercial and development stage companies. She is board certified in internal medicine, pulmonary medicine, and critical care medicine, completing her training at Johns Hopkins University, where she currently serves on the faculty.
1:00 – 1:15 PM | Questions and Comments
Dr. Linda Katz
Dr. Theresa Michele
1:15 PM | Adjournment