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Related
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21 CFR 11 Electronic Records; Electronic Signatures
21 CFR 50 Protection of Human Subjects
21 CFR 54 Financial Disclosure by Clinical Investigators
21 CFR 56 Institutional Review Board
21 CFR 99 Dissemination of Information on Unapproved New Uses for Marketed Drugs, Biologics, and
Devices
21 CFR 310 New Drugs
21 CFR 312 Investigational New Drug Application
21 CFR 314 Applications for FDA Approval to Market a New Drug
21 CFR 316 Orphan Drugs
21 CFR 600 Biological Products: General
21 CFR 803 Medical Device Reporting
21 CFR 812 Investigational Device Exemptions
21 CFR 814 Premarket Approval of Medical Devices
21 CFR 821 Medical Device Tracking Requirements
21 CFR 860 Medical Device Classification Procedures
21 CFR 1270 Human Tissue Intended for Transplantation
21 CFR 1271 Human Cells, Tissues, and Cellular and Tissue-Based Products
PL 107-108 Best Pharmaceuticals for Children Act
PL 108-155 Pediatric Research Equity Act of 2003
42 CFR 2a Protection of Identity—Research Subjects
45 CFR 46 Protection of Human Subjects
45 CFR 160 General Administrative Requirements (HIPAA)
45 CFR 162 Administrative Requirements (HIPAA)
45 CFR 164 Security and Privacy (HIPAA)
45 CFR 160 and 164 Combined HIPAA Regulations (compiled by Office of Civil Rights 2003)
Human Testing; Proposed Plan and Description of Review Process
Original Contributor:
Bruce Steinert, Evanston Northwestern Healthcare Research Institute
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