Drug Development: Role of the FDA and Sponsor
Understanding the history of the FDA, its role and the Sposnor's role in 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. This module has 2 required parts and 4 recommended videos. Once you have completed Part 2, please link to the evaluation after which you will be directed to a certificate of completion for your education records. Note that Part 1 certificate is provided after the course completion.
At the conclusion of this module, learners will be able to:
- Describe and explain the drug development and review process in the United States.
- Outline the role of Center for Drug Evaluation and Research (CDER) role in post-marketing safety surveillance for medical products.
- Identify ways CDER disseminates safety information about medical products to both healthcare professionals and their patients.
- Identify methods used by CDER to protect public health.
- Describe the role of the Sponsor in drug development.
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. Course was released on 2/25/16. Certificate of completion/CEs offered.
Role of the Sponsor (75 minutes)
NOTE: Audio quality is not the best, but the content is very good and thorough.
NOTE: Once you complete the evaluation, the certificate of completion will only be for the Role of the Sponsor since the FDA course provides its own certificate.