Compliance Tip of the Day: Crowd Sourcing Risk Intelligence
What is the CCF?
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?
The Product Regulation and Metrology Act 2025 reforms the UK's post-Brexit product safety, metrology, and consumer protection frameworks....more
The EU Data Act is one of the cornerstones of the EU's Data Strategy and introduces a new and horizontal set of rules on data access and use to boost the EU's data economy. Most of the provisions of the Data Act will become...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
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
On October 18, 2018, FDA released a new draft guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, which describes the Agency’s current thinking and recommendations on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On June 10, 2016, the U.S. Food and Drug Administration (FDA) issued a draft guidance advising manufacturers on appropriate and responsible dissemination of patient-specific information from medical devices....more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On January 22, 2016, the US Food and Drug Administration ("FDA") issued draft guidance outlining important steps medical device manufacturers should take to address cybersecurity risks in order to improve patient safety and...more
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