2020 CARES Act & OTC Drug Reform

Norma Skolnik

Norma Skolnik is Keynote Speaker at ComplianceKey. She has over 35 years of regulatory experience working with the pharmaceutical and dietary supplement industries. She served as Director of Regulatory Affairs for the Americas for Cadbury Adams. Prior to that, she was Director of Regulatory Affairs for the Adams Division of Pfizer and Associate Director of Regulatory Affairs for the Warner-Lambert company. She also served as Director of Regulatory Affairs for Lederle Consumer Healthcare, as Associate Director of Marketed Product Support for Lederle Laboratories and as Associate Director of Reg........

Overview

The recently passed 2020 CARES Act includes an important section that significantly reforms the regulatory framework for OTC drugs and makes important changes to how FDA regulates drugs marketed under an OTC Monograph. It is likely to yield greater OTC access to drug ingredients with strong safety profiles. It also allows for changes to be implemented by administrative orders instead of the current cumbersome notice and comment rule-making process - a major change that should speed up the drug review process. It also provides the incentive of 18 month market exclusivity and establishes user fee requirements. These are landmark changes and it's essential for all marketers of OTC drugs to learn about these important changes.

Why should you attend this webinar?

Anyone involved in the marketing of OTC drugs must learn about how these important changes to FDA's OTC Monograph process will impact their company's drug products. Sunscreen manufacturers need to understand how this Act impacts their products. Understanding how the new CARES Act Reform changes will affect current and future OTC drug products and replace the current OTC drug rulemaking process is critical for OTC Drug industry stakeholders.

Areas Covered in the Session:

How the OTC Drug Monograph Safety, Innovation & Reform Act replaces the FDA notice and comment rulemaking with an administrative order process.
How changes under the CARES Act help clarify the regulatory status of OTC drugs now subject to Tentative Final Monographs.
Pathways for new OTC active ingredients and new drug dosage forms for drug products under the Act.
FDA's 2019 proposed Sunscreen rules and how these will change under the CARES Act.
Changes for Sunscreen regulations under the CARES Act and amendment of the Sunscreen Innovation Act.
Next steps for FDA implementation that will impact OTC drug products in the USA.

Who can Benefit:

Regulatory managers and associates, R & D drug managers, Marketing managers and anyone involved in the development and marketing of U.S. OTC drug and sunscreen products should attend.