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In October 2023, the FDA released draft guidance entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: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
Promoting competition and innovation in Canada’s health sector, including the pharmaceutical industry, is a strategic priority for the Competition Bureau. In 2021, the Bureau announced that it joined its counterparts in the...more
The Department of Justice Antitrust Division has advised several pharmaceutical companies that they can share competitive information regarding the status of their respective efforts to develop a COVID-19 treatment without...more
Saudi Aramco’s slow trickle of IPO-related information continued this weekend, including its goal of setting overall company market value at a staggering $1.7 trillion. The figure, though massive, is still well short of the...more
This issue of Skadden’s semiannual Cross-Border Investigations Update takes a close look at recent cases, regulatory activity and other key developments, including a review of the first year of GDPR enforcement, analysis of...more
SAMHSA has released a long-awaited proposed rule that would modify the federal regulations at 42 CFR Part 2 (Part 2) governing the confidentiality of substance use disorder (SUD) patient records created by federally assisted...more
On August 26, 2019, the U.S. Department of Health and Human Services ("HHS") and the Substance Abuse and Mental Health Services Administration ("SAMHSA") issued a proposed rule amending the regulations governing the...more
On August 22, the Substance Abuse and Mental Health Services Administration (“SAMHSA”) announced a new proposed rule (the “Proposed Rule”) amending 42 CFR part 2 (“Part 2”), which is aimed at protecting patient records...more
On August 22, 2019, providers and other health industry participants involved in the provision of substance use disorder (SUD) services got some welcome news in the form of proposed regulatory changes. The U.S. Department of...more
Hospitals and Health Systems Prepare for a Value-Based Future - Editor’s Note: Hospitals and health systems are actively working to service their communities in numerous ways, including through the adoption of initiatives...more
The Peltz/P&G drama continues, with the company suggesting that Trian has lost its bid for a Board seat and the fund arguing that it disagrees with the company’s counting of the ballots....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