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Food and Drug Administration (FDA) › Annual Reports

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

Smart & Biggar

Medical Devices updates: Annual performance report, new guiding principles for PCCPs for machine learning-enabled medical devices,...

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Medical Devices Directorate Performance Annual Report - In September 2023, Health Canada published the Medical Devices Directorate Performance Annual Report for April 1, 2022, through March 31, 2023. The report provides...more

Alston & Bird

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

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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, USDA, and CDC release annual report announcing the sources of foodborne illness

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On 18 December 2020 the Interagency Food Safety Analytics Collaboration (IFSAC) announced the release of its 2018 annual report on the sources of foodborne illness involving the pathogens Salmonella, Escherichia coli (E....more

Hogan Lovells

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

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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

Foley & Lardner LLP

The Era of Personalized Medicine Has Arrived - PMC’s Annual Progress and Outlook Report

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The Personalized Medicine Coalition (PMC) released its annual “Personalized Medicine At FDA: A Progress & Outlook Report” (Report) that monitors current successes and challenges in bringing personalized therapies to market....more

Jones Day

Food, Dietary Supplement & Cosmetics Update | Vol. IV, Issue 3

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FDA Amends Waivers to Sanitary Transportation Rule - On April 6, 2017, the Food and Drug Administration ("FDA") notified industry regarding the amendment of waivers available under the Sanitary Transportation of Human...more

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