FDA :Office of the CISO - washington.edu

Office of the CISO

FDA

Food and Drug Administration Code of Federal Regulations (CFR)

UW Information

Description*

Additional Safeguards for Children in Clinical Investigations
(21 CFR parts 50, 56)

Investigational New Drug Application
(21 CFR part 312)

Investigational Device Exemptions
(21 CFR 812)

Subject Area:
Research, Children

UW Subject Matter Expert

Karen Moe, PhD
Director & Assistant Vice Provost for Research
Human Subjects Division, Office of Research
http://www.washington.edu/research/hsd/policy.php?browse=all

FDA Information

Websites:
Additional Safeguards for Children in Clinical Investigations
(21 CFR parts 50, 56)

Investigational New Drug Application
(21 CFR part 312)

Investigational Device Exemptions
(21 CFR 812)

Enforcement Commission: Food and Drug Administration

*A brief description is provided by the UW Subject Matter Experts to assist the UW community; it is not a legal description or an official description from the external authority, and should not be construed as legal advice.