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Final Guidance Disclosure Requirements Medical Devices

McCarter & English, LLP

FDA Finalizes Guidance on Communications Regarding Unapproved Uses of Medical Products

In January 2025, the US Food and Drug Administration (FDA) finalized its 2023 revised draft guidance Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more

Goodwin

How to (Finally) Get Your SIUU Out: FDA Issues Final Guidance on Communicating Off-Label Scientific Information

Goodwin on

On January 7, 2025, FDA announced the availability of a final guidance document titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...more

McDermott Will & Emery

FDA Finalizes Guidance on Payor Communications

McDermott Will & Emery on

On June 12, 2018, the US Food and Drug Administration (FDA) finalized its Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers guidance (Final Guidance)....more

Cooley LLP

FDA Holds Teleconference re: Social Media Guidance

Cooley LLP on

The U.S. Food and Drug Administration (FDA) held a webinar last week to discuss three recently released guidance documents related to regulatory requirements for pharmaceutical and medical device manufacturers, distributors...more

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