Four senators introduce bipartisan legislation to clarify breakthrough and accelerated approvals for novel non-opioid or non-addictive pain medication...
FDA releases its latest batch of Warning Letters that includes Hanbul Cosmetics Co., Luen Wah (HK) Medicine and SynCardia Systems.
FDA approves an Ultragenyx Pharmaceutical NDA for Crysvita (burosumab), the first drug approved to treat adults and children ages one year and older w...
FDA approves an Abbott firmware update for its implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators due to bat...
Federal Register notice: FDA makes available a guidance on Highly Concentrated Caffeine in Dietary Supplements.
FDA says it has qualified the use of a patient-reported outcome instrument for exploratory use to measure symptoms of non-small cell lung cancer.
Federal Register notice: FDA seeks comments on an information collection extension for Permanent Discontinuation or Interruption in Manufacturing of C...
FDA releases a draft guidance for industry entitled Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study ...