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.
Pfenex files a 505(b)(2) NDA for PF708, referencing Eli Lillys osteoporosis drug Forteo.
FDA clears a Pear Therapeutics 510(k) for its mobile medical application to help increase retention in an outpatient treatment program for individuals...
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.