FDA posts a revised draft guidance entitled Current Good Manufacturing Practice Guidance for Human Drug Compounding Outsourcing Facilities Under Sect...
Federal Register notice: FDA announces a 2/12 Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee meeting to discuss vag...
Federal Register notice. FDA issues an order debarring physician Su-Chiao Kuo for three years from providing services in any capacity to a person that...
Federal Register notice: FDA has issued an order debarring David J. Fishman for three years from providing services in any capacity to a person that h...
AdvaMed identifies guidance documents that FDA should prioritize in its fiscal year 2019 plan on proposed documents to be developed.
FDA issues Pfizers Hospira drug unit a Form FDA-483 after inspecting the firms McPherson, KS sterile drug manufacturing site.
FDA issues a safety communication on reprocessed duodenoscopes after interim study results show higher-than-expected contamination rates after reproce...
FDA Review posts the Federal Register notices for the week ending 12/7/2018.