Understanding the U.S. Food and Drug Administration

Join us as Kelly Stone, MD, PhD, FAAAAI, explains the evolution of the U.S. Food and Drug Administration and its central role in ensuring the safety and efficacy of therapeutics in the United States. We discuss the modern drug approval process from preclinical development through clinical trials and post-marketing surveillance and explore what makes this pathway different for biologics and biosimilars so you have a better understanding of the therapeutics that we prescribe every day in the clinic.BiosimilarsMedWatch:The FDA Safety Information and Adverse Event Reporting Program FDA HistoryDrug Development Process