Food and Drug Administration Amendment Act

Food laws, British, 23 160-161. See also Food Additives Amendment of 1958 Food and Drug Administration Modernization Act of 1997 (FDAMA) Food Chemicals Codex (FCC) Food Quality Protection Act of 1996 (FQPA) Food manufacturing aids, 12 66-67... 

Medical devices were first made subject to FDA regulation under the FD C Act of 1938. At that time, the statute included no requirement for premarket testing or approval. Congress enacted the Medical Device Amendments of 19766 to require pre-market notification for all medical devices, and pre-market approval for some old and new devices for which there is no adequate assurance of safety and effectiveness. The 1976 Amendments established a broad new array of statutory requirements and enforcement provisions. This new regulatory approach was supplemented by the Safe Medical Devices Act of 1990 3 and further refined by the Medical Device Amendments of 1992,61 Food and Drug Administration Modernization Act of 1997,6 jj g Medical Devise User Fee and Modernization Act... 

In the mid-1990s, FDA and the EU began discussions to harmonize cGMP-type inspections. Specifically, in 1997, Congress enacted the Food and Drug Administration Modernization Act (FDAMA), which amended the FDC Act, to encourage FDA to support the Office of the U.S. Trade Representative, in consultation with the Secretary of Commerce, in... 

Other laws impact FDA s operations. For example. The Food and Drug Administration Modernization Act of 1997 and Prescription Drug User Fee Act Amendments of 2002 give authority to FDA to collect user fees for review of certain marketing applications. They also set performance goals for the Agency to meet review timelines (http //WWW. fda.gov/cder/pdufa/). 

On the national level, oversight is generally restricted to medical devices, and not on operational matters. Federal jurisdiction of medical devices falls under the purview of the Department of Health and Human Services, Public Health Service, Food and Drug Administration (FDA), Center for Devices and Radiological Health. Under federal law, medical devices are regulated under the Medical Device Amendments of 1976 and the Radiation Control for Health and Safety Act of 1968. Additional regulatory authorization is provided by the Safe Medical Devices Act of 1990, the Medical Device Amendments of 1992, the FDA Reform and Enhancement Act of 1996, and the Food and Drug Administration Modernization Act of 1997. ... 

A primary responsibility of the Food and Drug Administration (FDA) is the enforcement of the Federal Food, Dmg, and Cosmetic Act of 1938 and its various amendments, eg. May, 1976, in which dental materials, instmments, and equipment are included. Premarketing clearance requirements apply for estabhshing the safety and effectiveness of new products. There is a close Haison between the FDA and the ADA standards and certification programs. 

US Food and Drug Administration, Federal Food, Drug and Cosmetic Act (Amended 1997). Also available on the World Wide Web http //www.fda.gov/opacoiii/laws/fdcact/fdctoc.htm. 

Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. (Act No. 117 of October 16,1973 amended in 2009)], as well as their continued use by the U.S. Environmental Protection Agency (EPA) [Kavlock R, Dix D. J Toxicol Environ Health B Crit Rev 13(2-4) 197-217, 2010] and U.S. Food and Drug Administration (FDA) [U.S. Environmental Protection Agency (EPA) and U.S. Food and Drug Administration (FDA) TSCA (1976) Toxic Substances Control Act. United States Publ. Law 94-469, 90 Stat 2003, USA],... 

Young, F., Nightingale, S., Mitchell, W., and Beaver, L. (1989). The United States Drug Export Amendment Act of 1986 Perspectives from the Food and Drug Administration. International Digest of Health Legislation 40 246-252. 

Department of Health and Human Services, Food and Drug Administration (DHHS), and Center For Drug Evaluation and Research, Guidance for industry court decisions, ANDA approvals, and 180-day generic exclusivity under the Hatch-Waxman amendment to the Federal Food, Drug, and Cosmetic Act, DHHS, Washington, DC, March, 2000. 

The Pure Food and Drug Act established the Food and Drug Administration (FDA), which now oversees the manufacture and use of all foods, food additives, and drugs amendments (1938, 1958, and 1962) strengthened the law considerably. 

The use of antibiotics at any level in animal feed is strictly regulated by the Center for Veterinary Medicine of the Food and Drug Administration, acting under the US Food, Drug and Cosmetic Act of 1938 as amended in 1958 and 1963 (7). Twelve different antibiotics are approved for use in livestock feeds ... 

Delaney amendment Amendment to the Food, Drug, and Cosmetic Act of the Food and Drug Administration of the United States. The amendment states that food additives that cause cancer in humans or animals at any level shall not be considered safe and are, therefore, prohibited. 

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