FDA to 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 to win approval for ...

Healthy Returns: FDA chief Marty Makary on compounded GLP-1s, vaccines and China

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.

A baby food puree sold in Wisconsin was recalled for 'elevated levels' of toxin

The fruit puree contained elevated levels of patulin, a naturally occurring substance produced by molds that can grow in ...
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 ...

FDA chief warns U.S. is losing ground to China in early drug development, calls for faster trial approvals

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

Trump administration set to drop 2-study requirement for new drug approval

By removing the two study standards, new drugs could be available and approved with just one study, which may speed up the process.

FDA reverses course and will review Moderna’s mRNA flu shot, company says

The US Food and Drug Administration has reversed course and will review a new mRNA flu vaccine from Moderna, the pharmaceutical company said Wednesday, ...

Moderna Receives Refusal-to-File Letter from the U.S. Food and Drug Administration for Its Investigational Seasonal Influenza Vaccine, mRNA-1010

Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna ...

If you feed your cat this popular freeze dried food, stop immediately and check the lot number

Consumers who have the recalled cat food should stop feeding it to their cats and return it to the place of purchase for a refund.

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 ...