The top vaccine and biologics drug official in the U.S. Food and Drug Administration will step down in April. The agency made ...

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.

In a highly unusual move for a normally buttoned-up regulatory agency, a senior official with the US Food and Drug Administration held a call with reporters Thursday to defend the agency’s recent ...

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 ...

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 already authorizes the use of experimental drugs under what’s called “compassionate use,” for people with no other ...

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 ...

The FDA lost about 20% of its workforce after Trump took office last year. Now it wants to shrink approvals from as long as 29 months to as low as six.

As FDA itself observes, “devices of a new type that FDA has not previously classified … are ‘automatically’ or ‘statutorily’ classified into class III…, regardless of the level of risk they pose.” To ...