CDER's Small Business and Industry Assistance Program has developed a series of Web-based courses to educate regulated small pharmaceutical industry. Note that these courses take approximately 1-3 hours to complete.
The course describes best practices and procedures for timely, transparent, and effective communications between investigational new drug application (IND) sponsors and FDA at critical junctures in drug development.
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.
As this course was developed in 2011, parts of it are no longer current. On Friday, March 27, 2020, the President signed the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which includes an important legislative initiative that reforms and modernizes the way certain nonprescription, over-the-counter (or OTC) drugs are regulated in the United States. Please refer to the FDA website and the SBIA Webinar, “Monograph reform is here! Learn what to expect and how to prepare” for details.
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. [Updated: March 20, 2019]