Federal Register notice: FDA permanently debars Jessica Palacio from providing services to any person that has approved or pending drug product applic...
Philips Respironics recalls (Class 1) its OmniLab Advanced + Ventilator because the device may experience an interruption or loss of therapy.
An FDA advisory committee recommends the approval of a Guardant Health PMA for the Shield blood test for colorectal cancer screening in adults age 45 ...
Pfizers Hospira drug unit recalls (Class 1) several lots of buprenorphine HCl injection Carpuject units and labetalol HCl injection Carpuject units du...
FDA cites Laurus Labs (Hyderabad, India) over GMP deficiencies following a 12/2023 inspection at the firms active pharmaceutical ingredient manufactur...
FDA denies all five Ipsen Pharmaceuticals requests for agency actions on ANDAs for a generic form of Ipsens Somatuline Depot.
The FY 2023 GDUFA Science and Research Report examines GDUFA-funded research in eight priority areas affecting generic drug development and oversight.
CDER, CBER, and CDRH directors tell Congress they need additional legal authorities to be able to continue to provide the services patients and provid...
