Law professors from three universities say FDA commissioner Stephen Hahns misstatement of data supporting the convalescent plasma EUA is fueling conce...
Stericycle says second-quarter medical device and drug recalls remained high despite the economy shut down due to the Covid-19 pandemic.
FDA approves a Med-EL USA PMA supplement for the slim and lightweight Rondo 3 Audio Processor for use with its Synchrony Cochlear Implant.
FDA says it is removing a Boxed Warning about amputation risk on Janssens diabetes drug canagliflozins (Invokana, Invokamet, Invokamet XR) prescribing...
CBER updates its Calendar Year 2020 guidance agenda listing 28 planned guidances in four categories.
CDER publishes a MAPP describing responsibility in the Office of Generic Drugs for processing drug application ownership changes in the Orange Book.
FDA posts final determinations for three drugs under the drug efficacy study implementation program.
FDA publishes a draft guidance on designing clinical trials for cancer drugs in patients with central nervous system metastases.