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 ...

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 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 costs and speed development without compromising agency standards.
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.
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 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 ...
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.
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 ...

Pharma Seeks Relaxed FDA Oversight to Move Drugs to Over Counter

Drugmakers are urging the FDA to reassess the regulatory process of switching medications from prescription to ...

FDA agrees to review Moderna’s mRNA flu vaccine application in a reversal

The FDA is slated to make a decision on the flu shot on Aug. 5, which will allow Moderna to make the vaccine available for ...