FDA Publishes a Wide Range of Guidances in the Final Days of the Biden Administration

On March 9, 2026, the Food and Drug Administration (FDA) published a draft guidance, “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection.” The guidance is intended for foreign and domestic human and animal drug establishments manufacturing drugs regulated by the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER) and the Center for Veterinary Medicine (CVM). The guidance is also intended for combination product manufacturers for which CDER or CBER is the lead center.

In March 2026, the Food and Drug Administration (FDA) issued draft guidance for the industry, New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers, providing additional clarity on eligibility for and requests for 3-year exclusivity under the Federal Food, Drug and Cosmetic Act for qualifying drug products.

On February 23, 2026, the Food and Drug Administration (FDA) released a draft guidance entitled “Considerations for the Use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause.” This guidance is designed for targeted, individualized therapies for which randomized controlled trials are not practical due to a small patient population, and was previewed by the Commissioner in several public forums.

On February 3, 2026, the Consolidated Appropriations Act, 2026 (P.L. 119-75) became law and marked an important milestone in the bipartisan congressional effort to reauthorize the rare pediatric disease priority review voucher program. Section 6604 of this law extends the Food and Drug Administration’s (FDA) authority to issue priority review vouchers to encourage treatments for rare pediatric diseases through September 30, 2029.