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.
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.
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.
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.
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
This course is intended to help IND sponsors become familiar with applicable CMC statutes, regulations, and relevant documents.
This course provides the essential steps of submitting electronic submissions to CDER, and can serve as a resource for questions about the submission process.
- 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.
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.