Federal Register notice: FDA makes available a final guidance on IRB reviews of individual patient expanded access requests.
FDA posts test performance data from four antibody test kits from an independent performance validation study effort with the National Institutes of H...
FDA grants AlgoTherapeutix an orphan drug designation for ATX01 (topical amitriptyline) for treating erythromelalgia.
FDA reissues certain emergency use authorizations to identify specific respirators that can be decontaminated for reuse.
A new FDA drug quality annual report finds that the agency in 2019 performed 1,258 drug quality surveillance inspections, with 42% of these conducted ...
CDER Office of Antimicrobial Products deputy director John Farley is named permanent director.
FDA posts a guidance on a temporary Policy to make it easier for drug firms to distribute drug samples During the Covid-19 public health emergency.