Federal Register notice: FDA makes available a draft information sheet guidance for sponsors, clinical investigators, and institutional review boards ...
FDA extends its PDUFA action date for Omeros narsoplimab BLA.
The Critical Path Institute names former FDA commissioner Robert Califf to its board.
Federal Register notice: FDA announces a 6/18 public meeting entitled FDA Public Meeting on Financial Efficiency of Human Drug User Fee Programs.
An FDA safety communication advises against taking an Covid-19 antibody test for those vaccinated with a Covid vaccine.
FDA issues an updated final guidance on 510(k) submissions for peripheral vascular atherectomy devices.
FDA issues a leapfrog guidance on non-clinical testing and clinical considerations for implanted brain-computer interface devices.
FDA issues a guidance on ANDA submissions for some highly purified synthetic peptides.