FDA says it is examining ways to modernize the medical device 510(k) process by relying more on a review that weighs new technologies that improve dev...
FDA issues a Form FDA-483 after an August inspection of a Cantrell Drug Co. outsourcing facility in Little Rock, AR.
FDA approves Genentechs ACTPen 162 mg/0.9 mL, a single-dose prefilled autoinjector for Actemra (tocilizumab) as an additional formulation for certain ...
FDA accepts for review a Biohaven Pharmaceutical Holding Co. 505(b)(2) NDA for BHV-0223, an investigational sublingual form of riluzole for treating p...
FDA classifies as Class 1 an Oscor recall of its TB Temporary Bipolar Pacing Leads due to connector separation that may cause a loss of pacing.
FDA Review posts the Federal Register notices for the week ending 11/23/2018.
Four stakeholders comment on an FDA report on the servicing of medical devices.
AdvaMed submits line-by-line comments to FDA on a draft guidance on considering uncertainty in medical device benefit-risk determinations.