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...
Federal Register notice: FDA seeks comments on an information collection extension entitled Shortages Data Collections.
FDA warns of a rare but serious risk of Drug Reaction with Eosinophilia and Systemic Symptoms associated with two anti-seizure drugs.
Acelyrin says it will have an independent auditor evaluate contractor research organization issues in trials for its izokibep.
FDA warns Tesuque, NM-based Dr. Bernes Whole Health Products that it is marketing adulterated unapproved eye drops.
