Manufacturers, Information Sharing

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

Skadden, Arps, Slate, Meagher & Flom LLP on 1/6/2023

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

Senate and House Make Progress in Passing the National Defense Authorization Act for Fiscal Year 2021

Stinson - Government Contracting Matters on 8/3/2020

A recent article on this blog reported on the contents of the Senate version of the National Defense Authorization Act for Fiscal Year 2021 (NDAA), which had been rolled out of committee for consideration by the full Senate....more

FDA Responds to Device Software Vulnerabilities by Releasing New Draft Cybersecurity Guidance

Mintz on 10/24/2018

On October 18, 2018, FDA released a new draft guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, which describes the Agency’s current thinking and recommendations on designing...more

FDA Issues Draft Guidance on Dissemination of Patient-Specific Information from Devices

Knobbe Martens on 7/5/2016

On June 10, 2016, the U.S. Food and Drug Administration (FDA) issued a draft guidance advising manufacturers on appropriate and responsible dissemination of patient-specific information from medical devices....more

FDA Clarifies Policy for Sharing Patient-Specific Data from Devices

Morgan Lewis on 6/15/2016

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

Alert: FDA Issues Draft Cybersecurity Guidance to Medical Device Manufacturers

Cooley LLP on 2/23/2016

On January 22, 2016, the US Food and Drug Administration ("FDA") issued draft guidance outlining important steps medical device manufacturers should take to address cybersecurity risks in order to improve patient safety and...more

CBP Expands Information Sharing Procedures to Help Detect Counterfeit Merchandise

McDermott Will & Emery on 10/20/2015

Effective October 19, 2015, U.S. Customs and Border Protection (CBP) implemented a final rule expanding CBP’s information sharing procedures with importers and trademark owners with respect to merchandise suspected of bearing...more

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