The content reflects current FDA thinking, emerging guidance, and real-world regulatory experience, providing participants with the most reliable and up-to-date information available. Organizations utilizing this training demonstrate their commitment to regulatory excellence and position their teams for successful interactions with health authorities worldwide.

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More about FDA’s Center for Drug Evaluation and Research’s (CDER) Small Business and Industry Assistance (SBIA) Program

CDER SBIA serves as the primary point of contact for pharmaceutical industry seeking to connect with the Agency. Our mission is to help you navigate FDA’s extensive regulatory landscape and master human drug product regulation requirements. Learn more here or watch our video below. Find additional resources for professional development in the CDER SBIA Learn Online Training Repository.