FDA makes available a guidance on Acne Vulgaris: Establishing Effectiveness of Drugs Intended for Treatment.
FDA posts a guidance entitled Bioanalytical Method Validation that discusses validating bioanalytical methods used in human clinical pharmacology, bi...
FDA clears an Inari Medical 510(k) for the FlowTriever System for treating pulmonary embolism.
FDA approves an AkaRx NDA for Doptelet (avatrombopag) tablets to treat low blood platelet count in adults with chronic liver disease who are scheduled...
FDA releases a three-page Form 483 sent to Auronext Pharma following a March inspection of the firms Bhjwadi, India manufacturing facility.
FDA accepts for review a Cosmo Pharmaceuticals NDA for Aemcolo (rifamycin SV MMX) for treating patients with travelers diarrhea.
Federal Register notice: FDA publishes a draft guidance on Cytomegalovirus in Transplantation: Developing Drugs to Treat or Prevent Disease.
Federal Register notice: FDA makes available a guidance entitled Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogona...