FDA Review posts the Federal Register notices for the week ending 2/22/2019.
FDA Review posts product approval summaries for the week ending 2/22/2019.
FDA posts a draft guidance entitled Implanted Brain-Computer Interface (BCI) 1 Devices for Patients with Paralysis or Amputation Non-clinical Testing...
FDA grants Imbrium Therapeutics an orphan drug designation for its investigational drug etoposide toniribate, intended for treating relapsed refractor...
FDA accepts for review an Alexion Pharmaceuticals supplemental BLA for the use of Soliris (eculizumab) in treating certain patients with neuromyelitis...
ICU Medical begins a Class 1 recall of one lot of ChemoLock Vial Spikes, 20mm due to the potential for plastic particles to break off the protective c...
FDA approves a Biotronik PMA for its Orsiro drug-eluting stent system.
FDA commissioner Scott Gottlieb and CDER director Janet Woodcock defend the agencys oversight of the generic drug industry to quash any doubt that gen...