Smiths Medical recalls its PneuPac paraPAC Plus 300 and 310 Ventilator Kits after receiving reports that the device may malfunction.
A Sidley petition comment response asks FDA to disregard comments on Sidleys orphan drug exclusivity petition made by former FDA orphan drug product d...
FDA approves a new indication for Vandas Fanapt to treat some adults with bipolar I disorder.
Representatives Eric Swalwell (D-CA) and Dan Crenshaw (R-TX) introduce bipartisan legislation to help address drug-gene interactions and to ensure tha...
FDA sends Contract Pharmaceuticals Limited a Form FDA-483 citing one observation after its Mississauga, Canada facility was inspected 10/2023.
Federal Register notice: FDA makes available a draft guidance entitled Data Integrity for In Vivo Bioavailability and Bioequivalence Studies.
A new HHS white paper on drug shortage policies cites many steps FDA has taken and wants to take in the future.
FDA approves Abbotts TriClip, a transcatheter edge-to-edge repair system that is designed for treating tricuspid regurgitation.
