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Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES).
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
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Poultry Products Inspection Poultry Products Inspection Act of 1957; 21 U.S.C. ch. 11 — Manufacture of Narcotic Drugs (repealed) 21 U.S.C. ch. 12 — Meat Inspection Meat Inspection Act of 1906; 21 U.S.C. ch. 13 — Drug Abuse Prevention and Control
[code of federal regulations] [title 21, volume 5] [revised as of april 1, 2015] [cite: 21cfr314.50] title 21food and drugs chapter ifood and drug administration department of health and human services subchapter ddrugs for human use part 314 applications for fda approval to market a new drug
An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format.It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.
Under the act, supplements are regulated by the FDA for Good Manufacturing Practices under 21 CFR Part 111. [2] The act was intended to exempt the dietary and herbal supplement industry from most FDA drug regulations, allowing them to be sold and marketed without scientific backing for their health and medical claims. [3]