FDA will drop two-study requirement for new drug approvals, aiming to speed access

The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies for new drug approvals ...
Becker's Hospital Review

FDA to drop 2-study requirement, expand OTC access

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.
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 ...
BioPharma Dive

FDA leaders say one pivotal trial, not two, should be ‘default’ for drug approvals

In a NEJM article, Commissioner Martin Makary and top deputy Vinay Prasad argued that the new policy should lower development costs and speed development without compromising agency standards.
Altoona Mirror

FDA to end 2-study rule for drugs

The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies to win approval for new drugs, the latest change from Trump administration officials vowing to ...
STAT

Ocular’s experimental eye drug beats low dose of Regeneron’s Eylea in late-stage trial

Ocular now plans to apply for FDA approval, but whether doctors and insurers will favor its new drug is an open question.

More than a third of patients on Wegovy pill are new to GLP-1 drugs, study finds

By Robin Respaut SAN FRANCISCO, Feb 11 (Reuters) - Among early users of Novo Nordisk'snew Wegovy weight-loss pill, 36% had no ...

FDA will drop two-study requirement for new drug approvals

WASHINGTON — The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies to win ...