Food and Drug Administration guidelines

Food and Drug Administration. Guideline for Drug Master Files, FDA, RockviUe, MD, 1989. 

U.S. Food and Drug Administration. Guideline on General Principles of Process Validation. Rockville, MD FDA, 1987. 

Clove oil is used as a safe anaesthetic for aquatic research. Tricaine or MS-222, the only anaesthetic registered in North America, is a very effective anaesthetic for several fish species but its application in the field is limited because the US Food and Drug Administration guidelines demand a 21-day withdrawal period after exposure to MS-222 before the fish enters the food chain. In this context, clove oil is found to be an alternative to MS-222 for use as a fish anaesthetic. Exposure of channel catfish (Ictalurus punctatus) to clove oil at a concentration of 100mg/l induced anaesthesia within 1 min. The fish recovered from a 10 min period of anaesthesia within 4 min after removal from the anaesthetic solution. 

Food and Drug Administration. Guidelines Manufacturing and Controls for INDs and NDAs. FDA Papers 5 4-14, 1971. 

U.S. Food and Drug Administration Guidelines for the Format and Content of the Clinical and Statistical Sections of New Drug Applications. July 1988. 

Abrams WB. 1993. Food and Drug Administration Guideline for the study of drugs in elderly patients an industry perspective . In Inclusion of Elderly Individuals in Clinical Trials, Wenger NK (ed.). Marian Mennel Dow Kansas 213-217. 

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