News & Analysis as of

Information Sharing Federal Food Drug and Cosmetic Act (FFDCA)

Skadden, Arps, Slate, Meagher & Flom LLP

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

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

Morgan Lewis

FDA Clarifies Policy for Sharing Patient-Specific Data from Devices

Morgan Lewis on

Device manufacturers may share patient-specific information from a device with the patient without violating federal privacy requirements....more

McGuireWoods LLP

DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished Prescription Drugs: How to...

McGuireWoods LLP on

On December 8, 2014, FDA issued new guidance, “DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers”. As the title suggests, the Guidance is part of FDA’s...more

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