The FDA has a complex and extensive set of requirements for sponsor-investigators (investigators who hold an IDE or IND). MICHR has developed training to initiate new sponsor-investigators to these responsibilities and assist them in compliance. An introduction to the FDA requirements is available in this recent presentation.
The following links provide information about FDA regulations regarding investigational products.
Resources on this page may not be an exhaustive list. If you know of other resources in this category, please let us know using the "Suggest a Resource" link at the bottom of the page.