Food and Drug Administration (FDA) Amendments Act of 2007
| Reviewed By | Internal Auditor Owner |
| URL: | https://www.nmu.edu/grantsandcontracts/human-subjects-research |
| Regulation Reference Cite | Public Law No. 110-85: 21 C.F.R. § 50; 21 C.F.R. § 56; 21 C.F.R. § 312; 21 C.F.R. § 314 |
| Level | Requirement |
| Oversight Unit | GRADUATE STUDIES & RESEARCH, COLLEGE OF |
| Person Responsible | TBD |
| Secondary Person Responsible | TBD |
| President / VP Level | Provost |
| Description |
For an investigational new drug to be used in a clinical investigation, the University must ensure the sponsor submits an Investigational New Drug Application and complies with all applicable requirements with respect to the regulations pertaining to human subjects and IRB review and approval. The regulation includes medical devices for human use as well as drugs. (Applies to federally-funded projects). Sponsors of certain clinical trials of drugs/devices regulated by the FDA must obtain informed consent from potential research subjects to submit their de-identified data to the ClinicalTrials.gov database. Specific language must be included in consent forms indicating that a description of the trial, but not any identifiable data, will be available through that database. Subjects who do not consent will not be permitted to participate in the trial. |
| Contacts and Data Sources |
| Dr. Susy Ziegler; Janelle Taylor |
| Internal Notes |
| This compliance item has notes that are available internally to the oversight unit. Please contact the Risk Management Department for more information |