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Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). [1] It is divided into three chapters: Chapter I — Food and Drug Administration
Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)).
21 U.S.C. ch. 9 — Federal Food, Drug, and Cosmetic Act 21 U.S.C. ch. 10 — Poultry and Poultry Products Inspection Poultry Products Inspection Act of 1957
The food contact materials are described in the Code of Federal Legislation (CFR): 21 CFR 174 – 21 CFR 190. Important starting points are: 21 CFR 175 Indirect food additives: Adhesives and components of coatings; 21 CFR 176 Indirect food additives: Paper and paperboard components; 21 CFR 177 Indirect food additives: Polymers
[1] [2] The Title 21 amendments were signed into law on May 28, 1976, by the 38th President of the United States Gerald R. Ford. [3] The U.S. legislation enacted in 1976 amended the Food, Drug, and Cosmetic Act of 1938 signed by the 32nd President of the United States Franklin D. Roosevelt. [4]
With respect to the FDA, the required components, controls and policies for an eTMF used in US based clinical trials follow US FDA CFR 21 Part 11 requirements. In August 2003, the FDA issued additional guidance to the industry that outlines the required components, controls, policies and validation required for electronic systems and electronic ...
If the FDA detects a problem, it may place a clinical hold on the IND, prohibiting the start of the clinical studies until the problem is resolved, as outlined in 21 CFR 312.42. An IND must be labeled "Caution: New Drug – Limited by Federal (or United States) law to investigational use," per 21 CFR 312.6
Code of Federal Regulations, Title 21, Part 312, Investigational New Drug Application ; Code of Federal Regulations, Title 21, Part 201.56 (and Part 201.57) CDER Guidance for Industry. Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products — Content and Format. CDER Guidance for Industry.