The content provides step-by-step guidance for accurate, compliant submissions through CDER Direct. The resources combine regulatory requirements with real-world applications, featuring practical case studies and compliance frameworks that streamline your submission process.
Browse courses available on demand:
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.
