Food Drug Administration

U.S. Food Drug Administration, Code of Federal Regulations. Title 21—... 

Since the U.S. vs. Barr decision in 1993 (relevant to pharmaceuticals and related fields, rules applied by the Federal Food Drug Administration, FDA), outlier tests may no longer be applied to physicochemical tests, under the assumption that such test methods, having been optimized and validated for the particular set of circumstances, rarely produce outliers. These tests may not be applied to CU results at all. Good manufacturing practices mandate that operators work according to pre-set procedures and write down any observed irregularities as they... 

Source Adapted from Francis, F.J., in Colorants, Eagan Press, St. Paul, MN, 1999 Commission Directive 95/45/EC, Ojf. J. European Commun., L226, 22.09, 1995 U.S. Food Drug Administration, Code of Federal Regulations, 21 CFR 73, 615 U.S. Food Drug Administration, Additives Listed for Use, etc., 1999 Downham, A. and Collins, P, J. Food Sci. Technol, 35, 5, 2000 JECFA, Geneva, 2001. 

US legislation on food additives consists of the Federal Food, Drug, and Cosmetic Act (FD C Act), the Fair Packaging and Labeling Act, and other applicable laws including the Public Health Security and Bioterrorism Preparedness and Response Act. The FD C Act states that foods are adulterated if they contain color additives that have not been approved as safe to the satisfaction of the Food Drug Administration (FDA) for a particular use. ... 

Source European Union (EU), US Food Drug Administration (FDA), and JECFA World Health Organization (WHO) regulations. ... 

Commission Directive 95/45/EC, July 26, 1995, laying down specific purity criteria concerning colors for use in foodstuffs. Off. J. Eur. Commun., L226, 22.09.1995. U.S. Food Drug Administration, Summary of color additives listed for use in the United States in food, drugs, cosmetics and medical devices, Washington, D.C., 1999. JECFA, online edition. Combined compendium of food additive specifications, http //WWW. fao. org. 

United States Food Drug Administration, Center for Food Safety Applied Nutrition. Foodborne Pathogenic Microorganisms and Natural Toxins Handbook. January 30, 2003. http //www.cfsan.fda.gov/ mow/preface.html. April 18,2005. 

Zemplar (paricalcitol) injection is a synthetically manufactured selective vitamin D receptor activator (SVDRA) indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (CKD) stage 5. The U.S. Food Drug Administration (FDA) approved a capsule form of Zemplar for development to satisfy a need for an oral formulation. The objective of study M04-693 was to assess the bioequivalencies of several dosage strengths of paricalcitol capsules under fasting conditions. 

HEALTH CANADA US,FOOD DRUG ADMINISTRATION HEALTH CARE WITHOUT HARM AMERICAN CHEMISTRY COUNCIL ... 

It is explained that the Food Contact Notification process of the US Food Drug Administration has been in place officially for three months This article asks, and then strives to answer, many questions about the system. 

EUROPEAN COMMISSION US,FOOD DRUG ADMINISTRATION GERMANY,FEDERAL MINISTRY FOR HEALTH EU EUROPEAN COMMUNITY EUROPEAN UNION ... 

EUROPEAN COUNCIL FOR PLASTICISERS INTERMEDIATES US,FOOD DRUG ADMINISTRATION US,ENVIRONMENTAL PROTECTION AGENCY... 

US,ENVIRONMENTAL PROTECTION AGENCY SOCIETY OF THE PLASTICS INDUSTRY US,FOOD DRUG ADMINISTRATION... 

This paper discusses how tightening environmental regulations in the USA are encouraging a shift from solvent-based to waterborne adhesives for use in flexible packaging applications. It also looks at how new adhesive systems have a relatively easy path to Food Drug Administration clearance for food packaging uses. 

Food Drug Administration, Olestra and Other Fat Substitutes, 1995 fda.gov/ opacom/backgrounders / olestra.html... 

While these external and internal factors already provided a difficult foundation, a routine investigation into the company by the US Food Drug Administration (FDA) identified areas of non-compliance with Good Manufacturing Practice (GMP) regulations. The resulting... 

The Food Drug Administration has the responsibility for the premarket clearance of all animal drugs. The 1958 food additive amendment to the Federal Food, Drug Cosmetic Act requires sponsors to demonstrate the safety of their products. The Kefauver-Harris amendment of 1962 requires the sponsors to demonstrate, in addition to safety, the efficacy of their drugs. Safety implies safety to the animal as well as to the consumers of animal products. The role of the Center for Veterinary Medicine in the premarket approval process is to establish conditions of drug use and to establish the allowable tolerances for drug residues in animal-derived food products. 

The decision to approve a new drug is made by a national regulatory body (Food Drug Administration in the U.S.A., the Health Protection Branch Drugs Directorate in Canada, UK Europe, Australia) to which manufacturers are required to submit their appUca-tions. AppUcants must document by means of appropriate test data (from predinical and clinical trials) that the criteria of efficacy and safety have been met and that product forms (tablet, capsule, etc.) satisfy general standards of quality control. 

Food Drug Administration (FDA). Protection of Human Subjects Code of Federal Regulations, Title 21, Part 50-55. Washington US Government Printing Office, 1997. 

Food Drug Administration (PDA). International conference on harmonisation, good clinical practice consolidated guidelines. Federal Register 1997 62 25692-709. 

Verber, J. "Shellfish Borne Disease Outbreak," Food Drug Administration, Northeast Technical Services Unit, Davisville, Rhode Island, 1984 pp. 18-20. 

Food Drug Administration. (2002) Black Box Warning For Serzon http //www.gene-sideeffects-law.com,... 

Food drugs are generally controlled through a common administration i.e. FDA (Food Drugs Administration in various states/country). The main objective of the Prevention of Food Adulteration Act is to make provision for the prevention of adulteration of food. The Act was passed in 1954 Rules under the Act were passed in 1955. 

Department of Health, Human Services, Food, Drug Administration. 21 CFR 330. Additional criteria and procedures for classifying over-the-counter drugs as generally recognized as safe and effective and not misbranded. Final Rule Fed Reg 2002 67(15) 3060-3076. 

Medical marijuana remains a controversial topic, but synthetic THC, dronabinol, marketed under the trade name Marinol, has been available by prescription since 1986. The dronabinol analog nabilone is another THC prescription drug marketed under the name Cesamet. Marinol and Cesamet, taken as capsules, have Food Drug Administration approval as an antinausea agent and appetite stimulant (for AIDS patients), but they are also prescribed for depression and muscle spasms. In 2005, Canada was the first country to approve Sativex, a cannabis spray that relieves pain in people with multiple sclerosis. 

Research at the US Food Drug Administration, stimulated me to suggest a specific term— pharmaco-informatics —to express the idea of a subdiscipline of pharmacology that focuses on the format and structure of the corpus of information that differentiates a medicine from a chemical. In the terms of the previous paragraph, it concerns the structure of the table of contents of the pharmaceutical user s manual . Transition to the infotensive age will... 

Food Drug Administration, Center for Drug Evaluation and Research, Draft Guidance for Industry, August 1999, ANDAs Blend Uniformity Analysis. 

The first edition of Catalytic Asymmetric Synthesis, published in the fall of 1993, was very warmly received by research communities in academia and industries from graduate students, research associates, faculty, staff, senior researchers, and others. The book was published at the very moment that the Food Drug Administration (FDA) in the United States clarified the situation in Chiral Drugs, the word chirotechnology was created, and chirotechnology industries were spawning in the United States and Britain. 

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