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 ...

FDA chief Marty Makary says 'everything should be over the counter' unless drug is unsafe or addictive

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

FDA Commissioner Says 'Everything Should Be Over the Counter.' Don't Count on Big Pharma To Lead the Way.

A system that allows drug makers to profit from restricted access will never liberalize on its own—and patients will continue ...
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 ...

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 ...
BioSpace

It’s Official: FDA Will Now Default to One Clinical Trial for Drug Applications

Drug sponsors should nevertheless bolster their application with “confirmative evidence,” chief regulators Marty Makary and Vinay Prasad said on Wednesday, including mechanistic data or findings from ...

FDA's reversal on Moderna flu shot bid followed White House pressure

President Trump called Commissioner Marty Makary to the White House to discuss his frustration with the agency handling of ...
pharmaphorum

Makary says FDA will "end two-trial dogma" for approvals

The FDA plans to adopt a new policy that will do away with the default requirement to base regulatory filings for new medicines on two pivotal trials, according to Commissioner Marty Makary.
Becker's Hospital Review

FDA to drop 2-study requirement, eyes broader OTC access

FDA drop study requirement shifts to one study for new drugs, expanding OTC access and easing regulatory pathways for prescription switches.
The American BazaarOpinion

FDA Commissioner says drugs should be OTC by default

FDA Commissioner Marty Makary says he believes "everything should be over the counter" unless a drug is unsafe, addictive or ...
European Medical Journal

FDA ends ‘two-trial dogma’ in historic shift

The FDA has announced that a single clinical trial will now be the default requirement for the approval of novel medicines.