The CDER Office of Pharmaceutical Quality issues a MAPP for its product quality assessors on consistent assessment of excess volumes in injectable dru...
Columbia University College of Physicians and Surgeons psychiatry chair Jeffrey Lieberman makes the case for Robert Califf to return to FDA as commiss...
FDAer Brooke Higgins discusses aseptic processing issues at a PDA/FDA joint regulatory conference.
FDA accepts for review a Samsung Bioepis sBLA for a high-concentration Humira biosimilar.
FDA clears a Helios Cardio 510(k) for CardiaMend Pericardial and Epicardial Reconstruction Matrix, indicated for both pericardial repair and reconstru...
Federal Register notice: FDA announces that CDER, CBER, CDRH and Center for Tobacco Products have modified their organizational structures.
FDA clears a Meridian Bioscience 510(k) for the Curian Campy assay, a rapid, qualitative fluorescent immunoassay for detecting Campylobacter-specific ...
Federal Register notice: FDA sends to OMB an information collection extension entitled Obtaining Information To Understand Challenges and Opportunitie...