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Pharmaceutical Industry › Food and Drug Administration (FDA) › Information Sharing

Epstein Becker & Green

Sharing Scientific Information with HCPs on Unapproved Uses of Medical Products: Dos and Don’ts Under FDA’s New Draft Guidance

Epstein Becker & Green on

In October 2023, the FDA released draft guidance entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers...more

Skadden, Arps, Slate, Meagher & Flom LLP

Trend Toward Broader Communication Continues as Congress Codifies Life Sciences Companies’ Ability To Share Product Information...

Skadden, Arps, Slate, Meagher & Flom LLP on

Embedded in the thousands of pages of the Consolidated Appropriations Act of 2023 (the omnibus legislation) that President Joe Biden signed into law on December 29, 2022, is a section that amends the Food, Drug and Cosmetic...more

Polsinelli

Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute

Polsinelli on

The U.S. Food and Drug Administration rejected Amgen Inc.’s request that biosimilars makers be forced to share their applications and manufacturing processes with competitors, exacerbating the company’s recent defeat in...more

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