Compliance Perspectives: The FBI on Why and How to Work with the Office of the Private Sector
The Compliance Challenge: Managing Legal & Regulatory Risk
Webinar: How to Get Your Lawyers Sharing Successfully on LinkedIn - with @AdrianDayton
Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
FCPA Compliance and Ethics Report-Episode 51-Interview with Tim Haidar
ACADEMI's Suzanne Rich Folsom and PwC's Glenn Ware on Moral Hazard
What Companies Should Do to Prepare for Implementation of Cybersecurity Executive Order
Where Does the Cybersecurity Executive Order Hit and Miss the Mark?
In October 2023, the FDA released draft guidance entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: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
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
On October 18, 2018, FDA released a new draft guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, which describes the Agency’s current thinking and recommendations on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
On June 10, 2016, the U.S. Food and Drug Administration (FDA) issued a draft guidance advising manufacturers on appropriate and responsible dissemination of patient-specific information from medical devices....more
Device manufacturers may share patient-specific information from a device with the patient without violating federal privacy requirements....more
On January 22, 2016, the US Food and Drug Administration ("FDA") issued draft guidance outlining important steps medical device manufacturers should take to address cybersecurity risks in order to improve patient safety and...more
On January 22, 2016, the Food and Drug Administration (FDA) issued draft guidance titled “Postmarket Management of Cybersecurity in Medical Devices,” setting forth proposed recommendations for the medical device industry as...more
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
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
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
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
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