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Medical Devices › Final Guidance › Prescription Drugs

McCarter & English, LLP

FDA Finalizes Guidance on Communications Regarding Unapproved Uses of Medical Products

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In January 2025, the US Food and Drug Administration (FDA) finalized its 2023 revised draft guidance Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more

Foley Hoag LLP

FDA Finalizes Guidance on Scientific Information on Unapproved Uses (SIUU) Communications

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On January 6, 2025, FDA published a final version of its guidance document, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products.” This...more

Foley & Lardner LLP

Scientific Information on Unapproved Uses of Medical Products: FDA’s Final Guidance on Firm Communication to Health Care Providers

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The U.S. Food and Drug Administration (FDA) recently announced final guidance for firms in the medical device and product industry titled, “Communications From Firms to Health Care Providers Regarding Scientific Information...more

Alston & Bird

Alston & Bird Health Care Week in Review - April 2022 #3

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...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

Faegre Drinker Biddle & Reath LLP

FDA Finalizes Voluntary Recall Guidance Imploring Companies to Be 'Recall Ready'

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The U.S. Food and Drug Administration (FDA) recently issued final guidance regarding the initiation of voluntary product recalls “to help companies prepare to quickly and effectively remove violative products from the...more

K&L Gates LLP

K&L Gates Triage: Q&A: What Sponsors and Investigators Need to Know about FDA’s ClinicalTrials.gov Reporting Requirements

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FDA’s recent release of new guidance on civil money penalties for the failure to submit required information to the ClinicalTrials.gov data bank may indicate a renewed interest in the enforcement of these requirements. On...more

Hogan Lovells

Appealing a denial of a drug/medical device export certificate: FDA final guidance

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Drug and medical device manufacturers seeking to export a product from the United States may need to obtain from the U.S. Food and Drug Administration (FDA) a Certificate to Foreign Government (CFG) in order to satisfy the...more

Smart & Biggar

Rx IP Update - March 2019

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Federal Court finds invalidity allegations relating to patent for metformin formulations not justified - On March 8, 2019, Justice Fothergill granted Valeant Canada’s application for an order prohibiting the Minister of...more

Hogan Lovells

FDA releases final guidance document on PMA manufacturing site change supplements

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On 17 December 2018 the U.S. Food and Drug Administration (FDA) issued a final guidance document intended to help manufacturers determine the appropriate premarket approval (PMA) application supplement reporting pathway for...more

King & Spalding

FDA and Life Sciences FDA Finalizes Guidances for “Consistent Communications” and Payor Communications

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A Summary of Final Guidances for Communications That Are Consistent with FDA-Required Labeling and Communications with Payors - On June 12, 2018, the Food and Drug Administration (FDA or Agency) finalized two draft...more

Cooley LLP

Blog: FDA Finalizes Two Guidance Documents Regarding Medical Product Communications

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The U.S. Food and Drug Administration (FDA) released two final guidances yesterday regarding medical communications: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities —...more

Hogan Lovells

Is it a drug, device, biologic, or combination product? FDA issues final guidance on classification

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On September 26, 2017, the Food and Drug Administration (FDA) published a final guidance document providing further clarity on how FDA classifies a product as a drug, device, biological product, or a combination product,...more

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