Former FDA commissioner Scott Gottlieb says the nation needs a coordinated national clinical trial infrastructure for use during public health emergen...
FDA revises its guidance on remote monitoring of clinical trials conducted during the Covid emergency and whether onsite monitoring should audit the r...
CDER issues Manuals of Policies and Procedures on scientific interest groups and data standards.
FDA clears a MiRus 510(k) for its IO Expandable Lumbar Interbody device for use in posterior and transforaminal fusion procedures.
FDA approves a UCB expanded indication for Briviact (brivaracetam) tablets, oral solution, and injection to treat partial-onset seizures in patients a...
FDA approves an Anixa Biosciences IND for its CAR-T (Chimeric Antigen Receptor-T cell) therapy and its use in treating ovarian cancer.
FDA revises its guidance entitled Conduct of Clinical Trials of Medical Products During the Covid-19 Public Health Emergency.
FDA grants a de novo authorization to Zimmer Biomet and Canary Medical for their tibial extension for Persona IQ, the first smart knee for total knee ...