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Regulatory Information

DHHS Common Rule (45 CFR 46)

Investigational New Drug (FDA IND, 21 DFR 312)

Investigational Device Exemption (FDA IDE, 21 CFR 812)

Biological Products (FDA, 21 CFR 600)

Family Educational Rights & Privacy Act (FERPA, 34 CFR 99)

Protection of Pupil rights Amendment (PPRA, 34 CFR 98)