Guidance: Federal Regulations
- Regulations enforced by the Food and Drug Administration (FDA)
- 21 CFR 50 -- Protection of Human Subjects
- 21 CFR 56 -- Institutional Review Boards
- 21 CFR 11 -- Electronic Records; Electronic Signatures
- 21 CFR 312 -- Investigational New Drug (IND) Application
- Decision tree to determine an IND is required
- Bioavailability or Bioequivalence Studies--Decision tree to determine if an IND is required
- MICHR IND / IDE Investigator Assistance Program (MIAP)
- 21 CFR 812 -- Investigational Device Exemption (IDE) Application
- Exception from Informed Consent for Studies Conducted in Emergency Settings
- Use of Investigational Products When Subjects Enter a Second Institution - Information Sheet
- Regulations enforced by the Office of Human Research Protections (OHRP)
- FDA/OHRP University of Michigan Registration -- This page provides information frequently requested by sponsors regarding the University's compliance with new registration rules.
Created 4/17/2012
