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Life Sciences Executive Orders Biden Administration

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

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

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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

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

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

Dorsey & Whitney LLP

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

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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

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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

Foley Hoag LLP

CFIUS Year in Review

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CFIUS reviewed a record number of transactions in 2021 according to its most recent annual report – and shows no signs of slowing down. High technology (including quantum computing), life sciences, and green energy...more

Goodwin

Year in Review: Top Biosimilars-Related Regulatory Developments of 2022

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As 2022 comes to a close, we review Big Molecule Watch’s top five biosimilar regulatory developments of the year...more

Latham & Watkins LLP

Health Care & Life Sciences: Drug Pricing Digest - October 2022 #2

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2022 Medicaid Drug Rebate Program Summit Concludes: The annual Medicaid Drug Rebate Program Summit took place Oct. 12-14 in Chicago. Latham partner Christopher H. Schott spoke at two sessions: the panel “Ask the Attorneys:...more

McDonnell Boehnen Hulbert & Berghoff LLP

President Biden's Biotechnology and Biomanufacturing Executive Order: Funding

President Biden announced his signing of an Executive Order launching a major effort to enhance U.S. capabilities in biotechnology and biomanufacturing last week (see "President Biden Signs Executive Order on Biotechnology...more

Goodwin

Year in Review: Top U.S. Biosimilars-Related Regulatory Developments of 2021

Goodwin on

As 2021 comes to a close, Big Molecule Watch reviews the top five biosimilar regulatory developments of the year... President Biden Signs Orange Book Transparency Act - In January, we reported that President Biden...more

Jones Day

Executive Order on Promoting Competition in the American Economy: A Focus on Patent and Drug Law to Reduce Health Care Spending

Jones Day on

Each year, Americans spend more than $1,500 per person on prescription drugs. Critics calling for measures to lower prescription drug costs often cast blame on alleged abuses of patent and competition laws. To address these...more

Akin Gump Strauss Hauer & Feld LLP

President Biden’s ‘Promoting Competition’ Executive Order: Key Health Care Actions to Follow

As has been widely reported, earlier this summer, President Biden issued Executive Order (EO) 14036, “Promoting Competition in the American Economy.” The EO provides insight into how the Biden-Harris administration plans to...more

Proskauer - Life Sciences

President Biden’s Executive Order on Competition Signals Potential Changes Affecting Patents in the Healthcare Sector

On July 9, 2021, President Biden issued “Executive Order on Promoting Competition in the American Economy” (the “Executive Order”). The Executive Order was billed by the White House as “historic” and comparable to Teddy...more

Cooley LLP

Alert: President Biden’s Executive Order on Competition: Three Important Takeaways for Tech and Life Sciences Companies

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On July 9, President Joe Biden issued an executive order on “Promoting Competition in the American Economy.” With 72 initiatives and directives by more than a dozen federal agencies, the order seeks to aggressively “reduce...more

Goodwin

Biden Executive Order Targets Competition in Healthcare, Life Sciences to Spur Economic Activity

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On July 9, 2021, President Joe Biden issued an Executive Order (the “Order”) designed to promote competition in the American economy. The Order describes the administration’s concerns with competition in several markets,...more

MoFo Life Sciences

Vaccine Production And State Intervention In The U.S.

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During the COVID-19 pandemic, governments across the globe have become increasingly involved in the private sector. State-owned enterprises have long been common in Asia, but the pandemic has increased their prominence in...more

Hogan Lovells

Biden executive order kicks off government-wide review of supply chains

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On 24 February 2021, President Biden issued an Executive Order (EO) that launches an examination of America’s supply chains. See EO No. 14017, 86 Fed. Reg. 11849 (Feb. 24, 2021). The Administration’s ultimate goal is...more

Morgan Lewis

Insight: The Defense Production Act and the Biden Administration

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The Biden administration has vowed to invoke the Defense Production Act (DPA) to increase domestic production of essential supplies needed to respond to the coronavirus (COVID-19) pandemic. In this Insight, we address key...more

Morgan Lewis

Biden Leaves in Place Key Portions of Buy American Act Changes, Targets New Domestic End Product Test and Services

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President Joe Biden issued on January 25 an Executive Order on Ensuring the Future Is Made in All of America by All of America's Workers (EO). This EO leaves in place key portions of the prior administration’s July 15, 2019...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, January 2021 # 15

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In Washington: House Democrats are altering the House calendar to speed up passing a COVID-19 relief through a reconciliation package by mid-March. House Majority Leader Steny Hoyer (D-MD) announced that the House will not...more

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