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Part 312: Investigational New Drug Application
Subpart D: Responsibilities of Sponsors and Investigators
21 CFR 312.60 - General responsibilities of investigators.
Enforcement history
Companies cited for this
Warning Letters
Part 50: Protection of Human Subjects
Subpart B: Informed Consent of Human Subjects
21 CFR 50.20 - General requirements for informed consent.
Enforcement history
Companies cited for this
Warning Letters