Regulatory Evolution: US FDA and Key Amendments

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This lecture will provide an insightful overview of the evolution of the United States Food and Drug Administration (FDA) regulations, starting from the early Biologics and Food Drug Acts to the intricate framework of today's regulatory system. By examining historical incidents such as the Elixir tragedy and the Thalidomide crisis, we will explore how these events catalyzed significant regulatory refinements including the Kefauver–Harris Amendments. The discussion will also delve into the...