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.