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 ...
Federal Register notice: FDA makes available a draft guidance on medical device MRI-safety testing and labeling.
FDA Review posts the Federal Register notices for the week ending 8/2/2019.
FDA Review posts product approval summaries for the week ending 8/2/2019.
Federal Register notice: FDA makes available a draft guidance entitled Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers....