A CDER study examines generic nasal spray distribution factors that could speed the development of generic sprays.
FDA clears a Vivos Therapeutics 510(k) for its Vivos CARE (Complete Airway Repositioning and/or Expansion) appliances for treating adults with severe ...
FDA continues to evaluate information about the potential for differences in procedural outcomes between women and men undergoing implant of a left at...
A lengthy online newsletter written by several Skadden attorneys explores possible new theories of cybersecurity False Claims Act liability for life s...
FDA publishes a guidance describing CBERs standards recognition program for regenerative medicine therapies.
FDA warns Intas Pharmaceuticals about repeat CGMP violations at its drug manufacturing facility in Matoda-Sanand, Ahmedabad, India.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Cara Therapeutics Korsuva (difelikefalin acetat...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for G1 Therapeutics Cosela (trilaciclib), indicate...
