Food and Drug Administration requirements

Berliner, VR. (1974). U.S. Food and Drug Administration requirements for toxicity testing of contraceptive products. In Briggs, M.H. and Diczbalusy, E., eds. Pharmacological models in contraceptive development. Acta Endocrinol (Copenhagen) supp. 185 240-253. 

LDPE is nontoxic, and is commonly used in food packaging where Food and Drug Administration requirements must be met. It is also used in... 

Several very useful books on the subject of chemical process development have been published.1 These have been written largely from the point of view of the bench chemist or chemical engineer. Emphasis in this collection of books is on the work needed to ensure that practical chemical reactions are created for scale-up, that the chemistry is understood, that the theory and mechanics needed to engineer scale-up are addressed, and that Safety, Environment and Food and Drug Administration requirements are met. 

Extract (alcoholic solution as per Food and Drug Administration requirements, at least 35% vol. of alcohol). 

Food and Drug Administration. Requirements of Laws and Regulations Enforced by the U.S. Food and Drug Administration. U.S. Department of Health, Education, and Welfare, Public Health Service, HEW Publication (FDA) 79-1042, 1979. 

Malinowski, H. I, and Marroum, P. J. (1999), Encyclopedia of Controlled Drug Delivery, vols. 1 and 2, Food and Drug Administration Requirements for Controlled Release Products, John Wiley Sons, New York, vol. 1, pp. 381-395. 

R., Hauck, W.W. et al., An individual bioequivalence criterion regnlatory considerations, Stat. Med. 19, 2821-2842, 2000 Meyer, M.C., United States Food and Drug Administration requirements for approval of generic drug products, J. Clin. Psychiatry 62 (Suppl. 5), 4-9, 2001 Temple, R., Policy developments in regulatory approval, Stat. Med. 21, 2939-3048, 2002 Gould, A.L, Substantial evidence of effect, J. Biopharm. Stat. 12, 53-77, 2002 Chen, M.L., Panhard, X., and Mentre, F, Evaluation by simulation of tests based on nonlinear mixed-effects models in pharmacokinetic interaction and bioequivalence cross-over clinical trials, Stat. Med. 24,1509-1524,2005 Bolton, S., Bioequivalence studies for levothy-roxine, AAPS J. 7, E47-E53, 2005. 

Cocchetto, D.M. The investigator s brochure a comparison of the draft international conference on harmonisation guideline with current food and drug administration requirements. Qual. Assur. 1995, 4, 240-246. 

According to the US Food and Drug Administration requirements, colloidon is an indirect food additive... 

The Food and Drug Administration requires that medication undergo rigorous testing before approving the medication. Testing includes the following animal studies to determine the medication s therapeutic index. A therapeutic index is a ratio between the median lethal dose and the median effective dose and indicates the safe dose to administer to the patient to achieve the therapeutic effect. These tests also provide scientists with information on how the medication is absorbed, distributed, metabolized, and excreted. 

Helphingstine CJ, Bistrian BR. New Food and Drug Administration requirements for inclusion of vitamin K in adult parenteral multivitamins. J Parenter Enteral Nutr 2003 27 220-4. 

The regulatory importance of specifications is highlighted in the Food and Drug Administration requirements for manufacturing information on drug products, which state ... 

The food you eat contains all kinds of nutrients. But how much of what things And is it healthful or "junk food" To help you make informed decisions about the food you choose to eat, the U.S. Food and Drug Administration requires manufacturers to place nutrition facts on the packages of processed foods. Look at the label shown here from a package of macaroni. Notice that the values of several substances are given as % Daily Value. Because it is important to know the percent composition for food, the labels... 

Regulatory Approval Capron conforms to Food and Drug Administration requirements of 21 CFR... 

What Does the Food and Drug Administration Require ... 

The Food and Drug Administration requires that for each device there be a device master file. The length and breadth of that rule becomes clearer when it is explained that the file need not be... 

The Food and Drug Administration requires that processed foods list the content of trans fatty adds. A diet low in saturated and trans fatty adds is recommended, along with more fish, whole grains, fruits, and vegetables. The recommendation is also for daily exercise, which is tremendously benefidak regardless of diet. 

Iloperidone is a novel antipsychotic drug which is a mixed dopamine D2/serotonin 5-HT2A receptor antagonist. In 2008, the US Food and Drug Administration required Vanda Pharmaceuticals, the manufacturers, to carry out a comparison of iloperidone with placebo and an active comparator such as olanzapine or risperidone [80 ]. It was finally approved in the USA in May 2009. 

NOTE WELL The Food and Drug Administration requires that fortified foods or foods that are labeled or advertised with a claim to their nutrition be labeled to show content, in terms of percent Recommended Daily Allowance, of protein, vitamin A, vitamin C, thiamin, riboflavin, niacin, calcium, and iron. Also, serving size and quantities per serving must be stated for calories, fat, protein, and carbohydrate. 

The Food and Drug Administration requirements for new compositions safety usually require clinical testing. Two clinical studies cost on the order of 300,000 to 500,000, for several years, often more than the total profit on prosthodontic materials and even larger than total sales for at least a ten-year period ... 

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