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Regulatory Requirements Life Sciences Executive Orders

Foley Hoag LLP - Security, Privacy and the...

DOJ’s “Bulk Sensitive Data Rule” is in Effect, and May Require Significant Compliance Obligations as Enforcement is Set to Begin

Pursuant to a newly effective U.S. Department of Justice (DOJ) regulation, the transfer and storage of certain sensitive U.S. government and personal data may be prohibited or restricted, depending on the intended recipient,...more

Cooley LLP

NIH Announces New Antidiscrimination Certification Heightening FCA Risk for Some Life Sciences Companies

Cooley LLP on

On April 21, 2025, the National Institutes of Health (NIH) announced a new civil rights term and condition of award for NIH grants, cooperative agreements and other transaction awards. The new term states that recipients of...more

Skadden, Arps, Slate, Meagher & Flom LLP

A 20-Minute Speech Provides the Clearest Road Map Yet for FDA Policy

Key Points - - Who is impacted: Manufacturers of pharmaceutical, biotechnology, medical device and food products. - What is changing: The agency is prioritizing user fee reauthorization, the MAHA initiative and a push for...more

Lathrop GPM

Trump Executive Order Restricts Funding for “Dangerous Gain-of-Function Research”

Lathrop GPM on

On May 5, the Trump administration issued Executive Order 14292, “Improving the Safety and Security of Biological Research,” which effectively ends federal funding for “dangerous gain-of-function research” and other life...more

Baker Donelson

DOJ Bulk Data Rule: Key Takeaways for Healthcare and Life Sciences

Baker Donelson on

The Data Security Program (DSP), implemented by the Department of Justice's National Security Division (DOJ/NSD) under Executive Order 14117 (Preventing Access to Americans' Bulk Sensitive Personal Data and United States...more

Hogan Lovells

How Trump’s reshoring EO affects plans to build or expand a domestic drug manufacturing facility

Hogan Lovells on

Investments in new (“greenfield”) or expanded (“brownfield,” “retrofit”) domestic manufacturing capabilities require years of strategic planning and capital expenditure. Even with the announcement of near-term incentives and...more

Akin Gump Strauss Hauer & Feld LLP

Improving the Safety and Security of Biological Research (Trump EO Tracker)

This Executive Order establishes a policy of the United States to ensure that federally funded research benefits American citizens without jeopardizing national security, strength or prosperity. The order seeks to strengthen...more

Morgan Lewis

Executive Order Targets Regulatory Barriers to Competition Across US Economy

Morgan Lewis on

President Donald Trump signed the executive order “Reducing Anti-Competitive Regulatory Barriers” on April 9, 2025, directing federal agencies to identify and reform regulations that unnecessarily restrict market competition....more

Skadden, Arps, Slate, Meagher & Flom LLP

Closing the GRAS Loophole: Secretary Kennedy’s Plan To Enhance FDA Food Safety Regulations

On March 10, 2025, Health Secretary Robert F. Kennedy Jr. initiated a significant shift in the regulation of ultra-processed foods by directing the Food and Drug Administration (FDA) to revise the GRAS (Generally Recognized...more

DLA Piper

Trump Administration’s DEI Executive Order and the Impact on FDA’s DAP Draft Guidance: Top Points

DLA Piper on

For more than a decade, the Food and Drug Administration (FDA) has made diversity in clinical trials a focus, including by issuing guidance, convening public-private workshops, and completing data analyses in an effort to...more

Ropes & Gray LLP

DOJ Issues Final Rule Restricting Flow of Bulk Sensitive Personal Data to China and Other Countries of Concern

Ropes & Gray LLP on

On January 8, 2025, the Department of Justice (“DOJ”) published its Final Rule to implement President Biden’s Executive Order 14117, “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States...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

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

Robinson+Cole Health Law Diagnosis

In Anticipation of COVID-19 Vaccine Approval, Connecticut Governor Ned Lamont Issues Executive Order To Facilitate Vaccine...

On December 7, 2020, Connecticut Governor Ned Lamont signed Executive Order No. 9Q (the “Order”) in anticipation of the approval of COVID-19 vaccines. The Order addresses and expands COVID-19 vaccine administration,...more

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