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

Drugmakers are urging the FDA to reassess the regulatory process of switching medications from prescription to ...

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 ...

The FDA plans to drop its long-standing requirement that drugmakers conduct two rigorous studies to secure approval for new drugs and is also pushing to expand over-the-counter access to medications.

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

The FDA’s drug review process can often be "unpredictable," and review teams typically “differ greatly” in what they ask of drug sponsors, Sen. Bill Cassidy said.

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

Makary helms the FDA in the midst of a contentious stretch for the agency, defined by massive staff and budget cuts and sweeping changes to vaccine policy.

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

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