Three stakeholders suggest changes to an FDA draft guidance on clinical trial diversity enhancement.
FDA approves Bracco Diagnostics Aribar Thin Liquid (barium sulfate) for oral suspension, indicated for modified barium swallow studies.
Abbott recalls its Ellipse Implantable Cardioverter Defibrillators after electrical failures had been identified.
Federal Register notice: FDA announces the rates for biosimilar user fees for fiscal year 2020.
A California federal court allows an amended complaint by Pharmaceutical Research and Manufacturers of America against a California drug pricing discl...
AbbVie files an NDA for elagolix, an oral gonadotropin-releasing hormone antagonist with a proposed indication for managing heavy menstrual bleeding a...
A JAMA viewpoint says legislation is needed to codify changes FDA is seeking to its medical device 510(k) program to reduce the reliance of equivalenc...
Foamix Pharmaceuticals files an NDA seeking approval for FMX103 foam for treating moderate-to-severe papulopustular rosacea in patients aged 18 years ...