News & Analysis as of

Biden Administration Life Sciences

Bergeson & Campbell, P.C.

President Trump Revokes 2022 EO on Advancing Biotechnology and Biomanufacturing

On March 14, 2025, President Trump signed Executive Order (EO) 14236, rescinding 19 executive actions, including former President Biden’s September 2022 EO 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a...more

Akin Gump Strauss Hauer & Feld LLP

FDA Publishes a Wide Range of Guidances in the Final Days of the Biden Administration

On January 6 and 7, 2025, the FDA announced, by our count, 31 draft or final guidances, on a wide range of topics. Historically, an incoming administration will impose a temporary freeze on the issuance of guidances and...more

Ropes & Gray LLP

FDA Finalizes Guidance on Predetermined Change Control Plans for AI-Enabled Medical Device Software

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On December 4, 2024, the U.S. Food and Drug Administration (“FDA”) released its final guidance for industry on predetermined change control plans (“PCCPs”) for devices that utilize artificial intelligence-enabled software...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Fourth Quarter of 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....more

Venable LLP

Venable’s BiologicsHQ Monthly Injection - April 2024

Venable LLP on

Welcome to Venable’s BiologicsHQ Monthly Injection – April 2024...more

Akin Gump Strauss Hauer & Feld LLP

Akin Intelligence - March 2024

Welcome to the March edition of Akin Intelligence. This month, the EU AI Act was approved by the European Parliament, moving one step closer to becoming the first major AI law. In the U.S., the DOJ brought criminal charges...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q2 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Foley Hoag LLP

Planning for the BIOSECURE Act

Foley Hoag LLP on

Members from both parties in the House and Senate have introduced legislation in both houses (H.R. 7085 / S. 3558) to bar federal agencies from entering into: Contracts, loans, or grant agreements for biotechnology...more

Proskauer - Minding Your Business

President Biden Announces New Price Fixing “Strike Force”: Government Continues Antitrust Crusade

Earlier this month, President Biden announced the formation of a “Strike Force on Unfair and Illegal Pricing.” This strike force will be an interagency group co-chaired by the FTC and DOJ. President Biden stated the group...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 2, March 2024

HHS Cybersecurity Performance Goals and the Healthcare Industry - The healthcare industry is a major target for cyberattacks because of all of the personal information collected from patients. Recognizing that the healthcare...more

Sheppard Mullin Richter & Hampton LLP

2024 Top-of-Mind Issues for Life Sciences Companies

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more

A&O Shearman

Senate Bill Introduced to Examine Bayh-Dole Reporting Requirements

A&O Shearman on

On January 10, 2024, Senators Chris Coons and Thom Tillis introduced a bill titled Improving Efficiency to Increase Competition Act (“IEICA”). The IEICA would require that the Comptroller General provide a report to certain...more

Akin Gump Strauss Hauer & Feld LLP

Congress and White House Press Ahead on AI in Health Care & Life Sciences

Last year, both Congress and the Biden-Harris administration noticeably increased their attention on Artificial Intelligence (AI). Key congressional committees explored AI implications for health care & life sciences, and the...more

Hogan Lovells

Biden Administration invites comments on new march-in rights framework

Hogan Lovells on

On Friday, December 8, the U.S. Department of Commerce's National Institute of Standards and Technology (NIST) opened for public comment its Draft Interagency Guidance Framework for Considering the Exercise of March-in...more

Skadden, Arps, Slate, Meagher & Flom LLP

FTC Enforcement Trends in Consumer Protection Under the Biden Administration

The Federal Trade Commission (FTC or the Commission) has continued aggressive regulation in the consumer protection space under the Biden administration. This persistent approach has occurred even in the face of recent...more

Fish & Richardson

Biden Administration Proposes March-In Rights Framework for Pharmaceutical Patents in Effort to Lower Drug Prices

Fish & Richardson on

On December 7, the Biden administration announced a proposed framework for determining whether the government may exercise its march-in rights to license pharmaceutical patents to third parties if it determines that the price...more

A&O Shearman

Biden Administration Releases New Proposed Framework for the Exercise of “March-In” Rights under Bayh-Dole

A&O Shearman on

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

Seyfarth Shaw LLP

Pill Politics: Unveiling Biden’s Bold Blueprint for Affordable Drugs

Seyfarth Shaw LLP on

On December 7, 2023, the Biden administration announced a blueprint for a framework that may be a tough pill to swallow for the pharmaceutical industry. This framework suggests that drug prices should be a crucial factor in...more

Foley Hoag LLP

Biden Administration Releases Draft Framework for Exercising Bayh-Dole March-in Rights Taking Into Account Drug Prices

Foley Hoag LLP on

On December 7, the White House announced “New Actions to Lower Health Care and Prescription Drug Costs by Promoting Competition,” which included “a proposed framework for agencies on the exercise of march-in rights on...more

Blank Rome LLP

Biden Administration Prioritizing Domestic Production of Pharmaceuticals . . . Again?

Blank Rome LLP on

On November 27, the Administration announced another blue-ribbon panel to bolster the domestic manufacturing of pharmaceuticals. This one is called the Supply Chain Resilience Council. Co-chairs of the Council are Lael...more

Dorsey & Whitney LLP

AI and Healthcare: More Guidance and Regulations are Coming to Town

Dorsey & Whitney LLP on

There is no doubt that artificial intelligence (“AI”) and more specifically, generative AI, is one of the hottest topics in healthcare for 2023. There is also no doubt that it will continue to be a hot topic into 2024 and...more

Skadden, Arps, Slate, Meagher & Flom LLP

AI Insights: Biden Administration Passes Sweeping Executive Order on Artificial Intelligence

On October 30, the U.S. government released its long-awaited, sweeping executive order (the AI EO or Order) on artificial intelligence (AI). The Order directs various U.S. government departments and agencies to evaluate AI...more

King & Spalding

President Biden's Executive Order on AI - Legal Practice Snapshots

King & Spalding on

On October 30, 2023, President Biden published a landmark Executive Order regarding the use of Artificial Intelligence (“AI”) with an accompanying Fact Sheet, touching on the opportunities these systems present along with...more

Epstein Becker & Green

White House Executive Order on Artificial Intelligence: Implications for the Health Care and Life Sciences Industries

Epstein Becker & Green on

On October 30, 2023, President Joe Biden signed the first ever Executive Order (EO) that specifically directs federal agencies on the use and regulation of Artificial Intelligence (AI). A Fact Sheet for this EO is also...more

Cozen O'Connor

Broad Street Brief: Hydrogen Hub Comes to Region

Cozen O'Connor on

Mayor Kenney Signs Executive Order Protecting Gender-Affirming Care for Transgender People- On Tuesday, Mayor Jim Kenney issued an executive order prohibiting the city from using any resources to investigate or punish...more

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