Drug Development: Role of the FDA and Sponsor
Understanding the history of the FDA, its role and the Sponsor’s role in the drug development process will provide research team members with a better understanding of how their roles fit into the process. For those investigators who also serve as a sponsor, it is important to understand what that entails and for the research team, what other responsibilities might be required of them. The five required parts of this module are from the “Introduction to the Principles and Practice of Clinical Research” course regarding FDA Product Regulations from February 2023. There are seven recommended videos.
Once you have completed the required parts, please complete the evaluation after which you will be directed to a certificate of completion for your education records.
Module Objectives
At the conclusion of this module, learners will be able to:
- Describe the historical perspective of the FDA's regulations governing drug development.
- Explain the drug development and review process in the United States.
- Describe the roles of the Sponsor and investigator in the conduct of clinical trials.
- Identify the mechanisms in place for monitoring the safety of drugs and biologics.
- Explain the importance of study data standards throughout drug development.
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Part 1 | FDA Product Regulations Part 1 of 7 FDA’s Mission and Organization (28 minutes) | Resources | Evaluation |
Part 2 | FDA Product Regulations Part 2 of 7 Investigational New Drugs (INDs) (19 minutes) |
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Part 3 | FDA Product Regulations Part 3 of 7 IND Safety (14 minutes) |
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Part 4 | FDA Product Regulations Part 5 of 7 Licensing Applications for Drugs and Biologics (13 minutes) |
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Part 5 | FDA Product Regulations Part 7 of 7 Study Data Standards (16 minutes) |
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Recommended |
Videos: - How a Drug Becomes a Drug (4 minutes)
- How Do Drugs Get Their Name (5 minutes)
- Is There a Difference Between Brand Name Medications and Generics? (9 minutes)
- Early Clinical Trials (18 minutes) - Provides an overview of the drug development process from pre-clinical to early phase clinical trials. NOTE: This was a recommended video in the Trial Design Module as well.
FDA Product Regulations Part 4 of 7 Expedited Programs (9 minutes) FDA Product Regulations Part 6 of 7 Medical Devices and Combination Products (8 minutes) FDA’s Role in Public Health: Drug Efficacy, Safety, Quality, and Beyond (90 minutes)
This activity explains how U.S. public health policy has influenced and shaped the Food and Drug Administration (FDA) protections that Americans have come to expect, provides an overview of FDA’s Center for Drug Evaluation and Research, or CDER’s, role in the regulation of new drug development, marketed drugs, quality testing, and post-market surveillance, and identifies new directions for the human drug regulatory process in the United States. Continuing Education credits are available through 6/7/2024.
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