Welcome to the Small Business and Industry Education Series, a group of Web-based tutorials aimed at educating small pharmaceutical business and industry on topics relating to drug regulation and review.
The mission of CDER's Small Business and Industry Assistance (CDER SBIA) Program is to promote productive interaction with regulated domestic and international small pharmaceutical business and industry by providing timely and accurate information relating to development and regulation of human drug products.
- Overview of the Generic Drug User Fee Amendments of 2012 (GDUFA)
- GDUFA Self-Identification (SPL) Submission – Part 1
- GDUFA Self-Identification (SPL) Submission – Part 2
Bringing an Over-the-Counter (OTC) Drug to Market Chemistry, Manufacturing, and Controls (CMC) Perspective of the IND
- Electronic Common Technical Document (eCTD)
Engaging with the FDA During New Drug Development Human Drug Establishment Registration and Drug Listing Compliance