FDA clears a ClaroNav 510(K) for NaviENT, a computer-assisted surgical navigation system for surgical procedures inside a patients skull.
Federal Register notice: FDA announces a 10/24-25 public meeting entitled 2017 Scientific Meeting of the National Antimicrobial Resistance Monitoring ...
Federal Register notice: FDA announces a 10/27 public workshop entitled FDA-University of Maryland CERSI Drug Development in Pediatric Heart Failure: ...
Federal Register notice: FDAs Dermatologic and Ophthalmic Drugs Advisory Committee meets 10/13 to review intraocular pressure drug.
Four FDAers analyze the agencys response to individual drug expanded-access requests over a four-year period and find that 98% were allowed to proceed...
Stakeholders offer FDA a variety of perspectives on how well the Waxman-Hatch amendments balance innovation and access.
FDA says that opioid addiction medications buprenorphine and methadone should continue to be given to patients taking benzodiazepines or other drugs d...
FDA tells Lipocine that the agencys Bone, Reproductive and Urologic Drugs Advisory Committee plans to discuss the companys NDA for Tlando, an oral tes...