[ Price : $8.95]
FDA issues Applied Therapeutics a complete response letter on its NDA for govorestat and its use for treating classic galactosemia...[ Price : $8.95]
FDA approves a Mentor Worldwide PMA for its MemoryGel Enhance Breast Implants for reconstruction breast surgery in post-mastectomy...[ Price : $8.95]
FDA publishes a guidance to help sponsors planning to use circulating tumor DNA as a biomarker in some cancer trials.[ Price : $8.95]
FDA releases the form FDA-483 with four observations from a 2023 inspection at the Monza, Italy-based Patheon Italia sterile drug ...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Recommended Follow-up Testing for an Ames-Positive Drug (Ac...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Assessment of Ovarian Toxicity in Premenopausal Adults Duri...[ Price : $8.95]
Federal Register notice: FDA renews its Oncologic Drugs Advisory Committee for an additional two years.[ Price : $8.95]
FDA identifies eight broad areas for the GDUFA FY 2025 science and research priorities.