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.
Federal Register notice: FDA announces a 10/22 Patient Engagement Advisory Committee meeting.
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FDA publishes a draft guidance on designing clinical trials for cancer drugs in patients with central nervous system metastases.
FDA accepts for priority review an EMD Serono NDA for once-daily, orally-dosed tepotinib for treating certain adult patients with metastatic non-small...
Five major stakeholders praise PDUFA performance to date and suggest improvements to be included in the 2022 PDUFA 7 reauthorization.