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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Sharing Scientific Information with HCPs on Unapproved Uses of Medical Products: Dos and Don’ts Under FDA’s New Draft Guidance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In October 2023, the FDA released draft guidance entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: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

Mintz

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

Mintz on

On October 18, 2018, FDA released a new draft guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, which describes the Agency’s current thinking and recommendations on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

Knobbe Martens

FDA Issues Draft Guidance on Dissemination of Patient-Specific Information from Devices

Knobbe Martens on

On June 10, 2016, the U.S. Food and Drug Administration (FDA) issued a draft guidance advising manufacturers on appropriate and responsible dissemination of patient-specific information from medical devices....more

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

Cooley LLP

Alert: FDA Issues Draft Cybersecurity Guidance to Medical Device Manufacturers

Cooley LLP on

On January 22, 2016, the US Food and Drug Administration ("FDA") issued draft guidance outlining important steps medical device manufacturers should take to address cybersecurity risks in order to improve patient safety and...more

Pillsbury Winthrop Shaw Pittman LLP

A Lifelong Commitment: FDA Releases Postmarket Guidance on Cybersecurity Risk Management for Medical Device Manufacturers

Pillsbury Winthrop Shaw Pittman LLP on

On January 22, 2016, the Food and Drug Administration (FDA) issued draft guidance titled “Postmarket Management of Cybersecurity in Medical Devices,” setting forth proposed recommendations for the medical device industry as...more

McGuireWoods LLP

Washington Healthcare Update

McGuireWoods LLP on

This Week: Because of the Blizzard of 2016—also known as “Snowzilla”—in Washington, D.C., and other parts of the East Coast, this is a combined issue... The House of Representatives opted not to come back to town until next...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

Cooley LLP

Blog: No More Paper PIs? FDA Issues Proposed Rule on Electronic Distribution of Prescribing Information

Cooley LLP on

Yesterday, the U.S. Food and Drug Administration (FDA) announced a proposed rule to require electronic distribution of the prescribing information intended for health care professionals (often called the “PI”) for human...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

King & Spalding

FDA Issues Draft Guidances Regarding Social Media: Handling Misinformation and Character Space Limits

King & Spalding on

On June 17, 2014, the U.S. Food and Drug Administration (FDA) issued two draft guidance documents concerning the use of social media and internet platforms for advertising and promotion: Internet/Social Media Platforms:...more

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