FDA removes a Spero Therapeutics clinical hold on a Phase 2 trial of SPR720, an investigational oral product being developed for nontuberculous mycoba...
FDA says it has temporarily postponed all face-to-face domestic and foreign inspectional work except for mission-critical inspections because of safet...
FDA releases an FDA-483 with seven observations from an inspection at Union, NJ-based Ideal Pharmacy.
Federal Register notice: FDA announces that its Office of the Chief Scientist has modified its organizational structure.
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.