Medical Device Legal News with Sam Bernstein: Episode 11
On November 21, 2024, the U.S. EPA released a new draft framework – the Interim Framework for Advancing Consideration of Cumulative Impacts – intended to provide EPA’s employees with guidance for how they should consider...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....more
The Biden administration appears steadfast in its efforts to lower prescription drug costs and continues to explore multiple avenues — even as the Medicare Drug Price Negotiation Program continues to move forward — to tackle...more
The Biden Administration’s recent publication of the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights and its request for comments on the draft guidance will impact how march-in rights...more
December 7, 2023, President Biden announced new actions to promote competition in health care and to lower prescription drug costs. Of particular note is a newly unveiled framework for deciding whether the Government may...more
On October 30, 2023, the Biden administration issued its long-awaited artificial intelligence (AI) executive order (EO), which issues directives to over 20 federal agencies, with the deadline for implementation spanning...more
Welcome to this week's issue of AI: The Washington Report, a joint undertaking of Mintz and its government affairs affiliate, ML Strategies. The accelerating advances in artificial intelligence (“AI”) and the practical,...more
Seyfarth Synopsis: Following President Biden’s comprehensive Executive Order on AI, the White House announced the formation of the “US AI Safety Institute” within the Commerce Department’s technology arm, the NIST. The...more
Throughout August 2023, the Office of Information and Regulatory Affairs, Office of Management and Budget, Executive Office of the President (“OIRA”) has held stakeholder meetings regarding a proposed rule which, if enacted,...more
vOn July 19, 2023, the U.S. antitrust enforcers, the Federal Trade Commission (“FTC”) and the Antitrust Division of the Department of Justice (“DOJ”) (collectively, the “Agencies”), released draft merger guidelines for public...more
On the heels of the historic proposed changes to the Hart‑Scott‑Rodino (“HSR”) merger review process, the U.S. Department of Justice Antitrust Division and the Federal Trade Commission released the 2023 Draft Merger...more
On September 22, 2022 the Biden-Harris administration announced a historic $7 billion funding opportunity to create regional clean hydrogen hubs (“H2Hubs”). One of the largest-ever public investments in clean hydrogen and in...more
Key Takeaways: The draft guidance represents the first-ever specific expectation by FDA that sponsors develop a diversity plan for trials. FDA’s recommendations come as part of increasing interest in ensuring clinical...more