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Gardner Law

FDA’s Center for Drug Evaluation and Research (CDER) Issues FY2023 Annual Report

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In January 2024, the Office of Compliance at the FDA’s Center for Drug Evaluation Research (CDER) released its Annual Report for FY2023. The Annual Report contains several useful pieces of information for drug companies and...more

Alston & Bird

FDA to Develop National Standards for Drug Distributors – Medical Products Supply Chain Week in Review

Alston & Bird on

Since our last update, the Senate confirmed Dr. Robert Califf as commissioner of the U.S. Food and Drug Administration. The FDA resumed domestic and foreign inspections. The agency also published a proposed rule to update...more

Hogan Lovells

FDA proposes annual summary reporting requirements for Right to Try drug sponsors, manufacturers

Hogan Lovells on

On July 23, the U.S. Food and Drug Administration (FDA) announced a new proposed rule that would require sponsors and manufacturers who provide an ‘‘eligible investigational drug’’ under the Right to Try Act to submit an...more

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