PharmExec

FDA Removes Two Study Requirement for New Drug Approval Process: Report

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

FDA Shifts Toward Single Trial Requirement for New Drug Approvals

A policy change allowing approval of some new drugs based on one adequate and well-controlled study could accelerate ...

FDA proposes new system for approving customized drugs and therapies for rare diseases

The FDA already authorizes the use of experimental drugs under what’s called “compassionate use,” for people with no other ...
The American Journal of Managed Care

FDA Will Require Only 1 Study to Approve New Drugs, Speeding Up Process

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 unveils proposal for streamlined approval of customized drugs for rare diseases

The FDA has proposed new guidelines to expedite the approval of customized treatments for rare diseases, creating a ...

FDA unveils new pathway for approving customized treatments for rare diseases

The FDA has proposed new guidelines to facilitate the approval of customized treatments for rare diseases, aiming to address ...