Contents

Link to the FDA Web site.

21 CFR 50—Human Subjects

Subpart A—General Provisions
Subpart B—Informed Consent
Subpart C—[Reserved]
Subpart D—Children in Clinical Investigations
 
21 CFR 56—IRBs
Subpart A—General Provisions
Subpart B—Organization and Personnel
Subpart C—IRB Functions and Operations
Subpart D—Records and Papers
Subpart E—Noncompliance
 
21 CFR 312—INDs
Subpart A—General Provisions
Subpart B—IND Application
Subpart C—Administrative Actions
Subpart D—Sponsors and Investigators
Subpart E—Drugs for Severe Illnesses
Subpart F—Miscellaneous
Subpart G—Lab Animals and In Vitro Tests
 
21 CFR 812—IDEs
Subpart A—General Provisions
Subpart B—Application and Administrative Action
Subpart C—Sponsors
Subpart D—IRB Review and Approval
Subpart E—Investigators
Subpart F—[Reserved]
Subpart G—Records and Reports
Miscellaneous FDA Documents
Significant Differences in FDA and HHS Regulations
What is a Biologic?
MRI Device Information

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