FDA Will Drop Two-Study Requirement for New Drug Approvals, Aiming to Speed Access U.S News February 18, 2026 ...

This move is another step in Makary’s attempts to shorten FDA reviews, which started when he began his tenure last year. 3 These include mandating the use of artificial intelligence for staffers and ...

FDA drop study requirement shifts to one study for new drugs, expanding OTC access and easing regulatory pathways for prescription switches.

Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug applications process ...

Drugmakers are urging the FDA to reassess the regulatory process of switching medications from prescription to over-the-counter, a rigorous procedure that must demonstrate a patient no longer needs a ...

In his report, Senator Bill Cassidy suggested a slate of changes to the FDA to support broader drug access and to reduce ...

The decision follows a pattern of policy shifts, including the rollback of COVID-19 recommendations and cancellation of mRNA funding.

Makary said the FDA is looking at prescription drugs like nausea medications and vaginal estrogen, and hopes to make changes this year.

After public backlash, the FDA will review a new mRNA flu vaccine. That's good news, but its original rejection and other arbitrary decisions undermine U.S. leadership in biopharmaceutical innovation.

Plasmalogen precursors for Alzheimer’s are named as first program candidate There are nutrients and dietary compounds ...