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Research and Development Regulatory Reform

Jenner & Block

Client Alert: White House Advances Development of New Artificial Intelligence Action Plan and R&D Strategy

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Recent activity by the White House Office of Science and Technology Policy (OSTP) highlights the Federal government’s ongoing focus on US leadership in artificial intelligence (AI) and opportunities for public input. On April...more

Morgan Lewis - As Prescribed

FDA's Recent Release of a Roadmap to Reduce Animal Testing

The US Food and Drug Administration (FDA) recently announced a strategic roadmap to phase out animal testing requirements for certain drug products, starting with monoclonal antibodies. This shift marks a significant change...more

Epstein Becker & Green

Executive Actions Impact Federally Funded Research: What Institutions Should Do Now – Diagnosing Health Care Video Podcast

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From removing diversity, equity, and inclusion initiatives to suspending foreign aid and canceling federal funding, it is clear that the current administration is drastically changing the landscape of government-funded...more

Health Care Compliance Association (HCCA)

New NIH Head: Indirect Payments ‘Tips’; Republican Senator Calls Them ‘Grift’

Research universities have had one less worry (at least temporarily) since Judge Angel Kelley of the U.S. District Court for the District of Massachusetts granted a preliminary restraining order prohibiting NIH from imposing...more

Snell & Wilmer

NIH Cuts and Potential Impacts on Intellectual Property

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On January 27th, the Trump administration issued an order (the January 27th order) freezing all federal grants and loans, which would have cut billions of dollars of federal funding, largely to research universities....more

Skadden, Arps, Slate, Meagher & Flom LLP

Under RFK Jr., US Health Policy and FDA Operations May See Major Shifts

Robert F. Kennedy Jr. (RFK Jr.) has been confirmed by the Senate as secretary of the Department of Health and Human Services (HHS). In this capacity, RFK Jr. will oversee 13 agencies that are critical to U.S. health policy,...more

Wiley Rein LLP

Capping It All Off: NIH Caps Indirect Rates for Grants

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SUMMARY: On February 7, 2025, the Office of the Director for the National Institutes of Health (NIH) issued a Notice (Notice No. NOT-OD-25-068) imposing a cap of 15% on the indirect cost rates that can be charged to the...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

ArentFox Schiff

Because . . . We Said So: Congressional Taxwriters Propose Tax Deal Including Significant Modifications to Employee Retention...

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Yesterday, the chairmen of the Senate Finance Committee and the House Ways and Means Committee introduced The Tax Relief for American Families and Workers Act of 2024 (the Act), which proposes changes to the child tax credit,...more

Troutman Pepper Locke

HHS Proposes Rescheduling Cannabis to Schedule III – What It Means for the Industry

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It has been widely reported and confirmed publicly that, on August 29, the U.S. Department of Health and Human Services (HHS) sent a letter to the Drug Enforcement Administration (DEA) recommending that cannabis be moved from...more

Davis Wright Tremaine LLP

White House Announcement Explores Measures to Regulate AI as Component of a National AI Strategy

On May 23, the Biden Administration announced several new initiatives to support the development of a National Artificial Intelligence (AI) Strategy. The initiatives focus on: (1) outlining a plan to increase federal...more

The Rodman Law Group, LLC

Medical Marijuana and Cannabidiol Research Expansion Act

With young adults’ marijuana use at an all-time high as states continue to pass legislation legalizing marijuana for medical and/or recreational use, the federal government is, at long last, taking a closer look. As we...more

Akin Gump Strauss Hauer & Feld LLP

Implementation Guidance for National Security Presidential Memorandum 33

Over the past three plus years, the issue of foreign influence over U.S. government-sponsored research has been front and center for the research community. There have been numerous high-profile prosecutions of professors,...more

Jones Day

White House Guidance on Implementing NSPM-33: Standardization of Disclosure and Security Measures for Federal Research Funding

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On January 4, 2022, the White House Office of Science and Technology ("OSTP") released guidance for federal agencies to implement National Security Presidential Memorandum 33 ("NSPM-33"). Issued in the final days of the Trump...more

Hogan Lovells

Election 2020 Snapshot: Helping our aerospace and defense clients make sense of the U.S. election results

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Election 2020 Snapshot: Helping our aerospace and defense (A&D) clients make sense of the U.S. election - The election of Joe Biden as the 46th President of the United States likely will result in significant shifts in U.S....more

Hogan Lovells

HHS now requires public posting of a decade of clinical trial results that were previously exempted

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Earlier this year, we wrote about a ruling by the U.S. District Court for the Southern District of New York that, if upheld, would require companies to make public a decade of clinical trial results for products that have...more

Hogan Lovells

FDA and OHRP Finalize Joint Guidance on IRB Meeting Minutes

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Ongoing Effort to Harmonize Human Subject Research Regulations The U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP), both part of the Department of Health and Human Services (HHS),...more

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