AbbVie files a supplemental NDA for Vraylar (cariprazine) for the adjunctive treatment of major depressive disorder in patients who are receiving ongo...
Federal Register notice: FDA publishes a proposed rule to amend medical device current GMP requirements of the Quality System Regulation to align more...
FDA says it will open notice-and-comment rulemaking to analyze the impact of a memorandum of understanding between it and states on the distribution o...
Three stakeholders comment on an FDA draft guidance on technical considerations for medical devices with physiologic closed-loop control technology.
FDA grants Noninvasix a breakthrough device designation for its LivOx Central Venous Oxygenation Monitor for monitoring central venous oxygen saturati...
CDER announces a 4/13 Webinar entitled Biosimilars: A Decade of Experience and Future DirectionsStrategies for Improving Biosimilar Adoption and the P...
Baxter International issues an urgent safety communication on upstream occlusion alarms for all Spectrum V8 and Spectrum IQ infusion pumps.
Ferring petitions FDA to require in vivo testing for ANDA and follow-on applications citing the companys Firmagon as the reference-listed drug.