The content provides access to current FDA thinking, emerging scientific approaches, and real-world application strategies that generic drug manufacturers need to succeed in an increasingly complex regulatory environment.

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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

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