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Life Sciences Compliance Attorneys Examine CARES Act OTC Drug Framework Overhaul

Practices: FDA Regulatory, Health Care, Digital Health, Regulatory Enforcement & Civil Litigation

Life sciences regulatory & compliance partner Al Cacozza and associate Jenna McCarthy (both of Washington, D.C.) co-authored a Law360 article that reviews incentives and risks for the over-the-counter (OTC) drug system overhaul under the CARES Act of the coronavirus stimulus legislation. 

The authors analyze the key provisions of the OTC monograph including an outline of the status of currently marketed OTC monograph drugs, a new administrative process to establish or amend a monograph, including expedited procedures for imminent public health hazards, an 18-month exclusivity period for certain administrative orders, creation of a user fee program, and proposed modifications to the Sunscreen Innovation Act of 2014.

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