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.
How the CARES ACT reforms the OTC Drug Monograph process by replacing current FDA notice and comment rulemaking 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 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.
*You may ask your Question directly to our expert during the Q&A session.
** You can buy On-Demand and view it at your convenience.
Skolnik is currently a Regulatory Consultant with over 35 years of
regulatory experience working with the pharmaceutical and dietary
supplement industries. She was Director of Regulatory Affairs for the
Americas for Cadbury Adams and Director of Regulatory Affairs for the
Adams division of Pfizer before that. Prior to that she was Associate
Director of Regulatory Affairs for the Warner-Lambert company and
Associate Director Regulatory Affairs at American Home Products