News & Analysis as of

Regulatory Reform › Food and Drug Administration (FDA) › Research and Development

Morgan Lewis - As Prescribed

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

Morgan Lewis - As Prescribed on

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

Latham & Watkins LLP

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

Latham & Watkins LLP on

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

Sheppard Mullin Richter & Hampton LLP on

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

Baker Donelson on

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

Morgan Lewis - As Prescribed

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

Morgan Lewis - As Prescribed on

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

Skadden, Arps, Slate, Meagher & Flom LLP

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

Skadden, Arps, Slate, Meagher & Flom LLP on

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

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

Troutman Pepper Locke

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

Troutman Pepper Locke on

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

Hogan Lovells

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

Hogan Lovells on

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

Hogan Lovells on

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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