Back to: FDA Clinical Investigator Training Course (CITC) 2024
Presenter
Kimberly Smith, MS, MD
Captain, United States Public Health Service
Senior Medical Advisor
Office of Medical policy (OMP)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Kimberly Smith is a nephrologist with the Real-World Evidence Analytics team in the Office of Medical Policy (OMP), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). In her current role, she develops and implements programs and policies related to the use of real-world evidence in drug development. Prior to her current role, Dr. Smith served at FDA as team leader for the Division of Clinical Trial Quality in OMP and as the nephrology team leader in the Division of Cardiology and Nephrology in CDER’s Office of New Drugs. Before joining the FDA, she was with the Coverage and Analysis Group at the Centers for Medicare and Medicaid Services.
Abstract
Kimberly Smith’s presentation offers a comprehensive overview of the FDA’s structure, mission, and regulatory framework for drugs and biologics. She emphasizes that the agency’s foundation stems from a history of public health failures, including unsafe medications and unethical practices, which historically drove the passage of crucial legislation. Key milestones discussed include the 1902 Biologics Control Act, enacted after a tetanus tragedy, and the 1938 Food, Drug, and Cosmetic Act, requiring new drugs to demonstrate safety before marketing due to a sulfanilamide incident. The 1962 Kefauver-Harris Drug Amendments further strengthened regulations by mandating proof of efficacy and enhancing safety controls, influenced by the thalidomide tragedy. Today, the FDA operates with over 18,000 employees, with its largest focus being the Human Drugs Program. The agency’s work is guided by the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, implemented through regulations and advisory guidance. A central component of its oversight is the Investigational New Drug (IND) application, which permits clinical studies in humans and allows the FDA to ensure participant safety and study quality. If concerns arise, the FDA can issue a clinical hold to delay or suspend an investigation. Upon completion of IND studies, sponsors submit New Drug Applications (NDAs) or Biologics License Applications (BLAs), providing extensive data for the FDA to determine if a product is safe and effective, if its benefits outweigh its risks, if labeling is appropriate, and if manufacturing methods are adequate for market approval.