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Regulatory Reform › Pharmaceutical Industry › Over The Counter Drugs (OTC)

Quarles & Brady LLP

Puerto Rico Repeals Special Authorization Requirement for Nonresident Manufacturers and Distributors

Quarles & Brady LLP on

In July 2022, the agency formerly known as the Puerto Rico Auxiliary Secretariat for Regulation and Accreditation of Health Facilities (SARAFS), now the Auxiliary Secretariat for the Regulation of Public Health (SARSP),...more

Troutman Pepper Locke

CARES Act Reforms Monograph System For Over-The-Counter Drugs

Troutman Pepper Locke on

Included in the CARES Act are long-awaited reforms to the FDA’s regulation of over-the-counter (OTC) medications. H.R. 748, §§ 3851-3862. The FDA has hailed the law as granting it “transformative, new authorities that will...more

Goodwin

U.S. CARES Act Enables Long-Awaited OTC Drug Regulatory Modernization: Key Highlights

Goodwin on

Subtitle F of the recently enacted U.S. CARES Act substantially reforms the regulatory framework for non-prescription drugs, representing the most significant update of the review process for over-the-counter (OTC) drugs...more

Hogan Lovells

At long last, landmark OTC Drug reform legislation is enacted

Hogan Lovells on

On March 27, 2020, as part of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), U.S. President Trump signed into law a long-awaited overhaul of the regulatory system for Over-the-Counter (OTC) drugs. ...more

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