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First Clinical Research Laws, Regulations & Guidelines

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 2 CFR 215 – Uniform Administrative Requirements for Grants and Agreements 
 2 CFR 220 Cost Principles for Educational Institutions 
 2 CFR 225 Cost Principles for State, Local and Indian Tribal Governments  
 21 CFR 1 – General Enforcement Regulations 
 21 CFR 2 General Administrative Rulings and Decisions 
 21 CFR 3 – Product Jurisdiction 
 21 CFR 5 – Organization 
 21 CFR 7 – Enforcement Policy 
 21 CFR 10 – Administrative Practices and Procedures 
 21 CFR 11 – Electronic Records; Electronic Signatures 
 21 CFR 12 – Formal Evidentiary Public Hearing 
 21 CFR 13 – Public Hearing before a Public Board of Inquiry 
 21 CFR 14 – Public Hearing before a Public Advisory Committee 
 21 CFR 15 – Public Hearing before the Commissioner 
 21 CFR 16 – Regulatory Hearing before the Food and Drug Administration 
 21 CFR 17 – Civil Money Penalties Hearings 
 21 CFR 19 – Standards of Conduct and Conflicts of Interest 
 21 CFR 20 Public Information 
 21 CFR 21 – Protection of Privacy 
 21 CFR 25 – Environmental Impact Considerations 
 21 CFR 26 – Mutual Recognition 
 21 CFR 50 Protection of Human Subjects 
 21 CFR 54 – Financial Disclosure by Clinical Investigators 
 21 CFR 56 – Institutional Review Boards 
 21 CFR 58 Good Laboratory Practice for Nonclinical Laboratory Studies 
 21 CFR 60 – Patent Term Restoration 
 21 CFR 99 – Dissemination of Information 
 21 CFR 210 – Withdrawal of Revision 
 21 CFR 300 – General 
 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 315 – Diagnostic Radiopharmaceuticals 
 21 CFR 316 – Orphan Drugs 
 21 CFR 320 Bioavailability and Bioequivalence Requirements 
 21 CFR 361 – Prescription Drugs for Human Use 
 21 CFR 600 – Biological Products: General 
 21 CFR 601 – Licensing 
 21 CFR 812 – Investigational Device Exemptions 
 21 CFR 814 – Premarket Approval of Medical Devices 
 42 CFR 2a Protection of Identity 
 42 CFR 3 – Amendments: Patient Safety and Quality Improvement 
 42 CFR 400 – Introduction; Definitions 
 42 CFR 403 – Medicare Special Programs and Projects 
 42 CFR 411 Exclusions from Medicare 
 42 CFR 417 – HMOs and Health Plans 
 42 CFR 423 – Voluntary Medicare Prescription Drug Benefit 
 42 CFR 424 Conditions for Medicare Payment 
 42 CFR 489.12 Federal Patient Self-Determination Act 
 42 CFR 1001 - Program Integrity Medicare and State Health Care Programs 
 45 CFR 46 – Protection of Human Subjects 
 45 CFR 60 National Practitioner Data Bank 
 45 CFR 61 Healthcare Integrity and Protection Data Bank 
 45 CFR 74 – Institutions of Higher Education, etc. 
 45 CFR 76 – Governmentwide Debarment and Suspension 
 45 CFR 92 – State, Local and Tribal Governments 
 45 CFR 160 – General Administrative Requirements 
 45 CFR 162 – Administrative Requirements 
 45 CFR 164 – Security and Privacy 
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