News & Analysis as of

Research and Development Regulatory Reform

Hogan Lovells

New FDA approval process promotes development of rare disease gene therapies

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The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known genetic defects will...more

Vicente LLP

Trump Signals Cannabis Rescheduling: Schedule III Marijuana Decision Expected Soon

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Key Takeaways - • President Trump’s administration is actively reviewing a proposal to move cannabis from Schedule I to Schedule III of the federal Controlled Substances Act (CSA) and a decision on rescheduling is expected...more

Cohen Seglias Pallas Greenhall & Furman PC

Key Changes to R&D, Construction, and Contract Actions

As discussed in our previous update, the FAR Council has been periodically publishing revisions to the Federal Acquisition Regulation (FAR). These revisions come on the back of the Trump Administration’s executive order...more

Morgan Lewis - As Prescribed

FDA’s New Priority Voucher Program for Drug Developers Ties Incentives to Defined National Interests

The US Food and Drug Administration recently announced the launch of a regulatory incentive program pilot program, the Commissioner’s National Priority Voucher Program (CNPVP), designed to reward drug and biologic sponsors...more

Schwabe, Williamson & Wyatt PC

Federal Acquisition Regulations Revised for R&D and Construction

The Federal Acquisition Regulatory (FAR) Council is undertaking a systematic approach to revising the Federal Acquisition Regulations (FARs). On July 24, 2025, revisions to FAR Part 35, Research and Development Contracting...more

Ropes & Gray LLP

HALT Fentanyl Act: Unpacking its Significant Reforms for Controlled Substance Research

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On July 16, 2025, President Trump signed the Halt All Lethal Trafficking of Fentanyl (“HALT Fentanyl”) Act into law. The law permanently reclassifies “fentanyl-related substances” into Schedule I of the Controlled Substances...more

Wilson Sonsini Goodrich & Rosati

FAR Part 35 Update: Making R&D Contracting More Accessible and Attractive

On July 24, 2025, the Office of Federal Procurement Policy (OFPP) and Federal Acquisition Regulation (FAR) Council published its latest rewrite to the FAR. We previously discussed this rewrite initiative—the Revolutionary FAR...more

Bergeson & Campbell, P.C.

EPA’s Office of Research and Development — Villain or Victim?

On July 18, 2025, the U.S. Environmental Protection Agency (EPA) rolled out the “reorganization plan” for its Office of Research and Development (ORD). The stated goal of the plan is to reduce budget expenditures, improve...more

Paul Hastings LLP

White House Releases AI Action Plan: "Winning the Race: America's AI Action Plan"

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On July 23, the White House released its strategic action plan on AI, “Winning the Race: America’s AI Action Plan” (the AI Action Plan), which is designed to secure U.S. global leadership in AI with a strategic focus on...more

Carlton Fields

“Restoring Gold Standard Science” Executive Order Steps Away From Biden Administration’s “Equitable” Approach

Carlton Fields on

Both President Trump’s and President Biden’s administrations have emphasized in executive orders and presidential memoranda the need for objective, science-based decision-making. However, Trump’s May 23, 2025, Executive Order...more

Morgan Lewis - As Prescribed

New Measures to Encourage Clinical Trials in the United Kingdom

While the US Food and Drug Administration has been experiencing recent reorganization and cuts in personnel, the United Kingdom has its own upcoming policy changes making it easier and faster to initiate and maintain UK...more

Latham & Watkins LLP

FDA and NIH Announce Initiatives to Reduce Animal Testing and Encourage Alternative Methodologies

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The initiatives reflect the latest measures from federal agencies to reduce and ultimately replace animal testing in drug development and biomedical research....more

Sheppard Mullin Richter & Hampton LLP

Reflections on the FDLI 2025 Annual Conference – Differing Tones, Shared Goals

From “gold standard science” to biopharma “GNC store”, this year’s Food and Drug Law Institute (FDLI) 2025 Annual Conference in Washington, DC, on May 15–16, a vital gathering for life sciences professionals, was full of...more

Baker Donelson

Executive Orders on Domestic Production of Critical Medicines and Biological Research Security

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What Happened? The President signed two companion Executive Orders (EO) on May 5, 2025 that collectively signal a significant federal pivot toward (i) accelerating the domestic manufacture of pharmaceuticals deemed "critical"...more

Health Care Compliance Association (HCCA)

And Then There Were Nine: Disappearing OHRP To Join Enforcement Agency; NIH Cuts Outlined

When it comes to changes roiling the federally supported research landscape, April offered no letup from the first three months of the year; if anything, the pace and magnitude increased. In one instance, an agency—the HHS...more

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

Wiley Rein LLP on

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...

ArentFox Schiff on

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

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