FDA publishes a guidance to help sponsors planning to use circulating tumor DNA as a biomarker in some cancer trials.
FDA releases the form FDA-483 with four observations from a 2023 inspection at the Monza, Italy-based Patheon Italia sterile drug manufacturer.
FDA publishes a guidance to help sponsors planning to use circulating tumor DNA as a biomarker in some cancer trials.
FDA releases the form FDA-483 with four observations from a 2023 inspection at the Monza, Italy-based Patheon Italia sterile drug manufacturer.
Federal Register notice: FDA makes available a draft guidance entitled “Recommended Follow-up Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Human Clinical Trials With Healthy Subjects.”
Federal Register notice: FDA makes available a draft guidance entitled “Assessment of Ovarian Toxicity in Premenopausal Adults During Drug Development for Oncologic Products.”
