Food and Drug Administration process for development and approval of drugs and radiopharmaceuticals: Treatments in urologic oncology

摘要: Abstract Regulatory advice and assessment play an important role in the successful development of new drugs radiopharmaceuticals for treatment urologic malignancies. Cooperation between US Food Drug Administration (FDA) pharmaceutical industry has led to approval more than 20 oncology products last 2 decades. Despite these advances, effective treatments need be developed approved This review provides general information about FDA׳s investigational drugs, with emphasis on regulatory process requirements marketing approval. In addition, this summarizes malignancies that were by FDA 30 years key issues concerning discussed publicly at Oncologic Advisory Committee meetings past 10 years.