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 ...
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 ...
Clinical Trials Arena 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.
Newsmax on MSN

FDA's Makary: All drugs should be OTC, unless unsafe, addictive

FDA's Makary: All Drugs Should Be OTC, Unless Unsafe, Addictive ...

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 ...

FDA's Marty Makary: Everything should be over-the-counter unless it's unsafe or requires monitoring

FDA's Marty Makary sits down with CNBC's Annika Kim Constantino to discuss the vaccine regulatory environment, compounding ...

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 ...
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 chief warns US 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 ...
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 ...
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.