A study of pediatric exclusivity trials finds that they have yielded useful information, but at a very high cost to consumers.
FDA clears an OrthoXel 510(k) for the Apex Tibial Nailing System, a fracture fixation device that can be surgically implanted from antegrade or retrog...
HHS cancels an FDA fetal tissue contract with Advanced Biosciences Research and opens an investigation into all fetal tissue research.
Endo extends the stay on a suit against FDA following an agency commitment to finalize its clinical need determination for vasopressin by 12/31.
FDA releases the FDA-483 with 16 observations from an inspection at the Pharm D Solutions outsourcing facility.
Neurelis files an NDA for Valtoco (diazepam nasal spray) as a treatment for epilepsy in patients six years and older who experience increased bouts of...
FDA clears a Renovis Surgical Technologies 510(k) to market the Tesera X Lateral Interbody Fusion System.
FDA issues three guidances relating to insanitary conditions at drug compounding facilities and to repackaging or compounding of radiopharmaceuticals.