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 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 ...
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 ...

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 ...

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 ...
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 ...
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 ...
Devdiscourse

FDA's Bold Move: Single Study Approval for New Drugs

The FDA plans to drop its requirement for two studies to approve new drugs, aiming to speed up the availability of medicines.
BioSpace

‘Just Agree to It:’ Pazdur Said He Was Told To Cosign FDA’s Reduced Trial Requirements

Richard Pazdur had spent 26 years at the FDA before stepping down last year due to disagreements with Commissioner Marty Makary about lowering the number of clinical trials required for a new drug ...