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 ...
GlobalData on MSN

FDA to allow one pivotal trial instead of two for drug approval

Prasad and Makary disagree that some may believe this move shows the FDA relaxing its standards.
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 ...

Physician tells Senate: ‘Something has gone seriously wrong in the FDA'

A Senate hearing probed whether the Food and Drug Administration's process for approving rare-disease therapies is ...
Medical News Today

What does FDA approval mean? A guide to understand the process

FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...
Fierce Biotech

'Like talking to a brick wall': Senate hearing takes aim at FDA's rare disease review process

A panel of physicians, biotech leaders and patient advocates took aim at the FDA during a Senate hearing Thursday on how the ...
Opinion
TownhallOpinion

FDA Cruelly Holding Up Approval of Treatments for Rare Diseases, Despite Children Likely to ...

The U.S. Senate Special Committee on Aging conducted a hearing on February 26 to investigate why the FDA is holding up the approval of desperately needed new drugs for those with rare diseases. Many ...

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 ...