openFDA

A new FDA Voices post from the agency's acting chief of staff details completed milestones and upcoming priorities across complete response letter disclosure, application lifecycle transparency, new a...

With a novel mechanism of action compared with existing marketed antidepressants, esketamine has been of keen interest to mental health clinicians and researchers. On March 5, 2019, the US Food and Dr...

How do you make good decisions when outcomes are uncertain or evidence is incomplete?

Objective To explain discrepant findings for fluoxetine's efficacy in three influential network meta-analyses (NMAs) of treatments for pediatric depression, which led to conflicting clinical recomme...

To me, this is a head-scratcher.

Abstract was not provided for this article.

Researchers urge inclusion of negative studies on drug labels

This Special Communication reviews the US Food and Drug Administration evaluation of 1 investigational drug (gepirone extended release) for major depressive disorder with conflicting evidence of benef...

Compliance with the FDAAA 2007 is poor, and not improving. To our knowledge, this is the first study to fully assess compliance with the Final Rule of the FDAAA 2007. Poor compliance is likely to refl...

Food and Drug Administration commissioner’s decisions have hurt staff morale and put his job in crosshairs

The U.S. Food and Drug Administration has reminded more than 2,200 medical product companies and researchers of the requirements to submit certain clinical trial results information to ClinicalTrials....

TikTok video by Michael Park, MD