A GCN report says FDA is relying on the Abbyy digital intelligence platform to analyze and summarize drug safety reports.
FDA grants Abbott an Emergency Use Authorization for over-the-counter, non-prescription, asymptomatic use of its BinaxNow Covid-19 Ag Self Test for de...
FDA says Apotex is recalling three lots of Guanfacine extended-release tablets after finding contamination in one lot.
FDA approves Sanofis Sarclisa (isatuximab) for combination use with carfilzomib and dexamethasone in treating adult patients with relapsed or refracto...
Federal Register notice: FDA amends its medical device regulations to make an editorial nonsubstantive change and replace a reference to an obsolete o...
Federal Register notice: FDA announces a 5/27 Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss a Provention Bio BLA for eplizu...
Federal Register notice: FDA announces a 5/26-27 workshop entitled FDA Science Forum 2021.
Federal Register notice: FDA amends its electronic import entries regulation to correct the statutory citation in the sections of that regulation requ...