title: Food and Drug Administration process for development and approval of drugs and radiopharmaceuticals: treatments in urologic oncology.
abstract: Regulatory advice and assessment play an important role in the successful development of new drugs and radiopharmaceuticals for the treatment of urologic malignancies. Cooperation between the US Food and Drug Administration (FDA) and the pharmaceutical industry has led to the approval of more than 20 new urologic oncology products in the last 2 decades. Despite these advances, more effective treatments need to be developed and approved for the treatment of urologic malignancies. This review provides general information about the FDA's role in the development of investigational new drugs, with an emphasis on the regulatory process and the requirements for marketing approval. In addition, this review summarizes the products for the treatment of urologic malignancies that were approved by the FDA in the last 30 years and the key issues concerning urologic oncology products that were discussed publicly at Oncologic Drug Advisory Committee meetings in the past 10 years.
authors.affiliation: Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD. Electronic address: ningy@cder.fda.gov.
authors.forename: Yang-Min
authors.initials: YM
authors.lastname: Ning
authors.affiliation: Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD.
authors.forename: V Ellen
authors.initials: VE
authors.lastname: Maher
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use; D017277:Drug Approval; D055808:Drug Discovery / Q000458:organization & administration; D015507:Drugs, Investigational; D006801:Humans; D007680:Kidney Neoplasms / Q000188:drug therapy; D008297:Male; D008495:Medical Oncology / Q000379:methods*; D011358:Product Surveillance, Postmarketing; D011471:Prostatic Neoplasms / Q000188:drug therapy; D019275:Radiopharmaceuticals / Q000627:therapeutic use*; D014481:United States; D014486:United States Food and Drug Administration; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy; D014572:Urology / Q000379:methods*
chemical_list: D000970:Antineoplastic Agents; D015507:Drugs, Investigational; D019275:Radiopharmaceuticals
keywords: Bladder cancer; FDA approval; Oncologic Drug Advisory Committee; Prostate cancer; Renal cancer; Treatments in urologic oncology