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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
"About Code of Federal Regulations". Government Publishing Office. 9 March 2017. "A Research Guide to the Federal Register and the Code of Federal Regulations". Law Librarians' Society of Washington, D.C. July 21, 2012. "Report to Congress on the Costs and Benefits of Federal Regulations". Office of Management and Budget. September 30, 1997.
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)).
For the most uptodate version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).6 New Search Help7 | More About 21CFR 8 [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
21 U.S.C. ch. 11 — Manufacture of Narcotic Drugs (repealed) 21 U.S.C. ch. 12 — Meat Inspection Meat Inspection Act of 1906; 21 U.S.C. ch. 13 — Drug Abuse Prevention and Control Controlled Substances Act, a part of the Comprehensive Drug Abuse Prevention and Control Act of 1970.
Download as PDF; Printable version; ... Pages in category "Code of Federal Regulations" ... Title 21 CFR Part 11; Title 47 CFR Part 15;
A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: . The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2).
The FDA requires nonclinical laboratory studies on new drugs, food additives, and chemicals to assess their safety and potential effectiveness in humans in compliance with 21 CFR Part 58, Good Laboratory Practice for Nonclinical Studies under the Federal Food Drug and Cosmetic Act and Public Health Service Act. [16]