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.
FDA Review posts product approval summaries for the week ending 12/7/2018.
CDER deputy Center director for clinical science Bob Temple accepts a new position at the Center Office of New Drugs senior advisor.
Indias Lupin Pharmaceuticals says FDA wrote up only "procedural" observations at three of its Mandideep generic drug manufacturing facilities.