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Guidance
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.
FDA guidance – General, Drug and Biologicals, Medical Devices, and FDA operations
IRBMED
| Approval Date:
November 2, 2020 3:15 pm
The term “test article” is found in the FDA regulations on Protection of Human Subjects (21 CFR 50.3, Definitions (j)). The term includes drugs (including botanicals, biologicals, and gene therapy, and genetically derived products that meet the definition of a “drug”), and medical devices for human use. The FDA has statutory authority to regulate the development and marketing of these products.
General
- Frequently Asked Questions
- Cooperative Research
- Non-local IRB Review
- Continuing Review After Study Approval
- Sponsor – Investigator – IRB Interrelationship
- Foreign Clinical Studies, Acceptance of
- Charging for Investigational Products
- Recruiting Study Subjects
- Payment to Research Subjects
- Screening Tests Prior to Study Enrollment
- Informed Consent, A Guide to
- Use of Investigational Products When Subjects Enter a Second Institution
- Exception from Informed Consent Requirements for Emergency Research
- “Off-Label” and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices
Drugs and Biologics
Medical Devices
Questions?
Contact us at [email protected] or 734-763-4768 / (Fax 734-763-1234)
2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800
A list of IRBMED staff is available in the Personnel Directory, or view the list of Regulatory Teams.
Edited By: [email protected]
Last Updated: November 02, 2020 3:15 PM