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)
Role of the Sponsor (75 minutes)
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.