FDA gives Catalent a four-page Form FDA-483 after inspecting the firms Bloomington, IN manufacturing facility 5/4-12.
Quidel Cardiovascular recalls the Quidel Triage Cardiac Panel after reports of inaccurate tests showing lower-than-expected troponin levels in samples...
FDA updates its final guidance entitled Qualification of Medical Device Development Tools (MDDTs).
Former FDA chief counsel Dan Troy joins Berkeley Research Group in the firms Washington, DC office as a managing director in its Health Analytics pra...
FDA approves an AstraZeneca BLA for Beyfortus (nirsevimab-alip) for preventing Respiratory Syncytial Virus lower respiratory tract disease in neonates...
Federal Register notice: FDA announces the issuance of a priority review voucher to Sarepta Therapeutics for its recently approved rare pediatric dise...
Federal Register notice: FDA and the Clinical Trials Transformation Initiative seek patient advocates interested in participating on the Patient Engag...
FDA issues Fresenius Kabis Canton, MA outsourcing facility a Form FDA-483 over GMP deviations observed during a March inspection.
