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...
FDA grants Theriva Biologics a fast-track designation for its lead clinical candidate VCN-01 in combination with gemcitabine and nab-paclitaxel for tr...
Pharmaceutical Research and Manufacturers of America asks FDA to address four issues relating to implementation of the FDA Reauthorization Act.
Vyaire Medical recalls (Class 1) its Twin Tube sample lines, which are used on the Vyntus CPX Cardiopulmonary Exercise Test, due to the potential for ...
Federal Register notice: FDA makes available a draft revised guidance entitled Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human...
