2020 CARES Act & OTC Drug Reform
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.
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.
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Contact Info :
Compliance Key
https://www.compliancekey.us/
Email : support@compliancekey.us
Phone : +1 717-208-8666
Speaker and Presenter Information
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.
Relevant Government Agencies
Dept of Health & Human Services, FDA, OTC Drug Reform
Event Type
Virtual
This event has no exhibitor/sponsor opportunities
When
Tue, Sep 1, 2020, 1:00pm - 2:00pm
ET
Website
Click here to visit event website
Organizer
Compliance Key
