The FDA has faced an extraordinary convergence of political, scientific, legal, and operational pressures over the last year.

Incentives to bring vaccines to market are shrinking. Drugmakers are scaling back research investments and cutting jobs.

FDA decisions lack majority consensus, experts agree, possibly leading to less nuanced verdicts on new drug applications.

FDA looks further ease biosimilar approvals by allowing foreign clinical data and reducing pharmacokinetic study requirements to cut costs.

The U.S. Senate has a plan to improve drug development for rare disease patients. The exit of controversial CBER chief Vinay Prasad will help clear the path.

On August 15, 2025, the U.S. Court of Appeals for the D.C. Circuit limited FDA's ability to deny a hearing on the approvability of a new drug application (NDA) based on a lack of “substantial evidence ...

The FDA is contemplating changing its medical device for software approval process, JD Supra reports. Here’s what you should know. 1. Software as a medical device applies to all software used to ...

The Food and Drug Administration has announced some major changes to the review process for drug developers in the United States. It could cut down the time from 10 to 12 months for a review to just ...

The Biologics Price Competition and Innovation Act of 2009 created the abbreviated approval pathway that biosimilars rely on, and the FDA has approved 82 biosimilars to date, with the new guidance is ...

The FDA plans to establish the Office of Drug Evaluation Science to improve and modernize the review process for new medications, according to STAT. The new office will help develop a standardized ...

MANILA, Philippines—The Food and Drug Administration (FDA) on Wednesday said the controlled destruction of infant formula products, earlier recalled by Nestlé Philippines, began this week, marking the ...

Months after promising help for “hundreds of thousands of kids,” the FDA approved the decades-old medicine for a disease documented in less than 50 people.