FDA Regulations Relating to Good Clinical Practice and Clinical Trials

Comprehensive List of Laws

• Laws Enforced by FDA and Related Statutes
• Federal Food, Drug and Cosmetic Act
   

 

FDA Regulations Relating to Good Clinical Practice and Clinical Trials

• 21 CFR Part 11 - ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
• 21 CFR Part 50 - PROTECTION OF HUMAN SUBJECTS (Informed Consent)
• 21 CFR Part, 50 supart D - Additional Safeguards for Children in Clinical Investigations of FDA-Regulated Products (Interim Rule)
• 21 CFR Part 54 - FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS Investigators
• 21 CFR Part 56 - INSTITUTIONAL REVIEW BOARDS
• 21 CFR Part 58 - GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
• 21 CFR Part 312 - INVESTIGATIONAL NEW DRUG APPLICATION
• 21 CFR Part 314 - APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
• 21 CFR Part 315 - DIAGNOSTIC RADIOPHARMACEUTICALS
• 21 CFR Part 320 - BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
• 21 CFR Part 361 - PRESCRIPTION DRUGS FOR HUMAN USE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH - Part 361.1 - Radioactive drugs for certain research uses
• 21 CFR Part 601 - APPLICATIONS FOR FDA APPROVAL OF A BIOLOGIC LICENSE
• 21 CFR Part 812 - INVESTIGATIONAL DEVICE EXEMPTIONS
• 21 CFR Part 814 - PREMARKET APPROVAL OF MEDICAL DEVICES

FDA Regulations Pertaining to Administrative Practices and Procedures.

• 21 CFR Part 10 - Administrative Practices and Procedures

FDA Regulations Pertaining to Regulatory Hearings.

• 21 CFR Part 16 - Regulatory Hearing Before the Food and Drug Administratration.

IND/NDA Preambles

• Federal Register Notice, 43 FR 35210 (August 8, 1978); Proposed Rule; Obligations of Clinical Investigators of Regulated Articles.
• Preambles to GCP Regulations