FDA approves an expanded use for Vertex Pharmaceuticals Orkambi (lumacaftor/ivacaftor) to include use in certain children ages two through five years ...
FDA approves magnetic resonance-conditional labeling for Envoys Esteem middle ear hearing implant.
FDA publishes a guidance on controlling elemental impurities of human drug products consistent with an International Council for Harmonization guidanc...
Four drug stakeholders ask for changes to an FDA draft guidance on including adolescents in adult oncology trials.
FDA clears a Cianna Medical 510(k) to broaden the indication of its SCOUT reflector for use in localization of soft tissue.
Federal Register notice: FDA announces an 11/5 public hearing on the future format of the National Drug Code.
FDA posts a draft guidance entitled Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment.
Federal Register notice: FDA makes available a draft guidance entitled Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products.