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On February 18, 2026, FDA Commissioner Martin Makary and Vinay Prasad, then-Chief Medical and Scientific Officer and Director of the Center for Biologics Evaluation and Research, published a landmark policy announcement in the New England Journal of Medicine that a single adequate and well-controlled pivotal trial — supplemented by confirmatory evidence — is now the…
Welcome to Part 5 of our 2026 Life Sciences Industry Outlook series. Today, we are wrapping up the week with a review of the regulatory environment for life sciences companies in 2025 and our expectations for what 2026 could bring. In 2025, life sciences companies faced a fast-moving regulatory environment shaped by the Trump administration’s…
On May 12, 2025, President Trump signed an Executive Order (“EO” or “Order”) “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” aimed at significantly reducing U.S. prescription drug prices by aligning them with the lowest prices paid by other developed nations. According to the EO, drug manufacturers “deeply discount their products to access foreign markets…
The FDA’s commitment to timely drug approvals under the Prescription Drug User Fee Act (PDUFA) has been a cornerstone of its regulatory framework. Historically, the agency has maintained a high success rate in meeting its PDUFA goals; however, a handful of delays will typically occur each year for largely idiosyncratic reasons. Since 2021, when the…
On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a new initiative to explore ways to reduce preclinical animal safety studies for human drugs and biological products, beginning with an approach to allowing the use of “New Approach Methodologies” (NAMs) in lieu of animal testing for eligible investigational monoclonal antibodies.[1] The agency’s…
Gibson Dunn is closely monitoring developments and is prepared to help companies consider and address the implications of potential changes to FDA’s funding structure and authorities, including through regulatory counseling, agency and legislative engagement, and litigation. Following recent mass layoffs at the Food and Drug Administration and growing criticism from senior administration officials of FDA’s…