2020 CARES Act & OTC Drug Reform

Product Id : FDA251
Instructor : Norma Skolnik
Aug 27, 2020 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes

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The recently passed 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.

Join this session by expert speaker Norma Skolnik, where she will illustrate why it’s essential for all marketers of OTC drugs to learn about these changes.

Session Highlights:

  • How the CARES ACT reforms the OTC Drug Monograph process by replacing current FDA notice and comment rule making with an administrative order process.
  • 18-month exclusivity provisions of the CARES Act and how they apply.
  • New user fee requirements for OTC monograph drug activities.
  • 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 under the Act.
  • Changes for Sunscreen regulations under the CARES Act and amendment of the Sunscreen Innovation Act.
  • Next steps for FDA implementation

Why Should You Attend:

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 products and replace the current OTC drug rulemaking process is critical for OTC industry stakeholders.

Who Should Attend:

  • Regulatory managers and associates
  • R&D Drug Managers
  • Marketing Managers and anyone involved in the development and marketing of U.S. 
  • OTC drug products should attend.OTC drug companies and Pharmaceutical companies
  • Consumer Healthcare Companies
  • Cosmetic companies that sell sunscreens and other OTC products.
  • Foreign companies that manufacture and export OTC drugs to the U.S.A.
Speaker Profile:

Norma Skolnik 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 Regulatory Affairs for Wyeth.

Norma currently works as a regulatory consultant and also enjoys coaching those who are just starting out in the consulting field

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