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  1. Development & Approval Process (Drugs)

Small Business and Industry Education Series

Small Business and Industry Education Series

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. These courses are part of CDERLearn, the web page for educational tutorials offered by the Center for Drug Evaluation and Research (CDER), and take approximately 1-3 hours to complete.

CDER SBIA’s mission is to engage with small pharmaceutical business and industry by providing timely and accurate information on human drug development and regulation.


Overview of the Generic Drug User Fee Amendments of 2012 (GDUFA)

  • This course informs the user about the GDUFA requirements and process, and can serve as a resource for better understanding of GDUFA. It addresses the rationale and benefits of GDUFA, the review and fee commitments under GDUFA, the metrics and goals associated with GDUFA, the self-identification process, and the drug master file changes required under GDUFA.

GDUFA Self-Identification (SPL) Submission – Part 1

  • This course is Part 1 of a two-part web-based training course on GDUFA Self-Identification SPL Submission. The overall goal of this training module is to provide a clearer understanding of mandatory information and its format for self-identification under GDUFA. It offers a comprehensive review of the required data elements and their restrictions for the Self-Identification SPL file.

GDUFA Self-Identification (SPL) Submission – Part 2

  • This course is Part 2 of a two-part web-based training course on GDUFA Self-Identification SPL Submission.  It focuses on guiding firms through a successful self-identification submission process, including uploading SPL submissions and retrieving acknowledgements.

Bringing an Over-the-Counter (OTC) Drug to Market

  • The purpose of this course is to provide information on navigating the rules and regulations on bringing an OTC drug to market and the associated FDA processes

Chemistry, Manufacturing, and Controls (CMC) Perspective of the IND

  • This course is intended to help IND sponsors become familiar with applicable CMC statutes, regulations, and relevant documents.

Electronic Common Technical Document (eCTD)

  • This course provides the essential steps of submitting electronic submissions to CDER, and can serve as a resource for questions about the submission process.

Engaging with the FDA During New Drug Development

  • This course focuses on familiarizing small pharmaceutical business and industry in general with resources available to communicate with FDA, and provides guidance on effectively interacting with FDA throughout the new drug development process.

Human Drug Establishment Registration and Drug Listing Compliance

  • This course identifies and discusses the statutory requirements regarding the submission of registration and drug listing information, and provides a clearer understanding of the registration and drug listing process.

Best Practices for Communication Between FDA and IND Sponsors During Drug Development

  • This course describes best practices and procedures for timely, transparent, and effective communications between IND sponsors and FDA at critical junctures in drug development.


Additional Information