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  1. CDER Small Business & Industry Assistance (SBIA)

FDA Advancing Generic Drug Development Training Modules

This training represents regulatory expertise developed by the scientists and reviewers who evaluate abbreviated new drug applications (ANDAs).

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.

Browse courses available on demand: 

SummaryCourse Description
Advancing Generic Drug Development: Translating Science to Approval 2024Transform your generic drug development strategy with knowledge on how cutting-edge regulatory science is revolutionizing ANDA approval pathways and accelerating time-to-market for complex generics.
Advancing Generic Drug Development: Translating Science to Approval 2023Gain strategic expertise in navigating regulatory pathways for high-value complex products while building essential knowledge for successful pre-ANDA planning and submission optimization.
Advancing Generic Drug Development: Translating Science to Approval 2022Understand FDA perspectives, research priorities, and regulatory assessment approaches that shape successful generic drug development strategies.

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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