The Role of the U.S. Food and Drug Administration Review Process: Clinical Trial Endpoints in Oncology

摘要

Marketing approval of drug products in the U.S. is governed by a rigorous review process conducted by the Food and Drug Administration (FDA). A sponsor must show that the drug is both safe and effective in adequate and well-controlled clinical trials in the patient population for which it is indicated. Drug development has evolved over the past 70 years, as legislation and advances in science have changed the Agency's requirements and interpretation of safety and effectiveness.