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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).
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
Where a RMAT's sponsor fails to comply with the requirements for accelerated approval, the RMAT designation and the benefits conferred by it can be withdrawn (21 CFR 601.43). Examples [ edit ]
"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.
21 U.S.C. ch. 6 — [Narcotic Drugs] (repealed or transferred) 21 U.S.C. ch. 7 — Practice of Pharmacy and Sale of Poisons in Consular Districts in China; 21 U.S.C. ch. 8 — Narcotic Farms (repealed) 21 U.S.C. ch. 9 — Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ch. 10 — Poultry and Poultry Products Inspection Poultry Products ...
From these legal authorities, CBER publishes regulations which are included in the first chapter Title 21 of the Code of Federal Regulations. Most of the regulations specific to CBER are found from 21CFR600-680. 21CFR1271 contains the rules for HCT/Ps.
Ingredients. 1 burger bun. 1/3 oz butter. 7 oz fresh ground Wagyu beef, formed into a patty. 3 slices fresh tomato. 2 pieces of Gem lettuce. 3 sweet pickles, sliced
All listed chemicals [5] as specified in 21 CFR 1310.02 (a) or (b). This includes supplements which contain a listed chemical, regardless of their dosage form or packaging and regardless of whether the chemical mixture, drug product or dietary supplement is exempt from regulatory controls. For each chemical, its illicit manufacturing use is ...