Agriculture, Rural Development, and Related Agencies Appropriations for 1982: Hearings Before a Subcommitee of the Committee on Appropriations, House of Representatives, Ninety-sixth Congress, First Session, Parts 5-6U.S. Government Printing Office, 1981 - United States |
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Page 24
... Evaluation , Food and Drug Administration . Ronald Kartzinel , M.D. , Director , Division of Neuropharmacological Drug Prod- ucts , Bureau of Drugs , Food and Drug Administration . Robert Katz , Ph . D. , Metabolic Desease Research ...
... Evaluation , Food and Drug Administration . Ronald Kartzinel , M.D. , Director , Division of Neuropharmacological Drug Prod- ucts , Bureau of Drugs , Food and Drug Administration . Robert Katz , Ph . D. , Metabolic Desease Research ...
Page 34
... evaluations of the drugs in the DESI and OTC reviews . Finally , the process of evaluation provides for significant public input through considerations of the applications by public meetings of scientific advisory committees , Freedom ...
... evaluations of the drugs in the DESI and OTC reviews . Finally , the process of evaluation provides for significant public input through considerations of the applications by public meetings of scientific advisory committees , Freedom ...
Page 53
... evaluations superimposed over previously recorded evaluations . The final evaluation can not be determined . Comment : Study personnel have been instructed in the manner in which observations will be recorded in order to preclude ...
... evaluations superimposed over previously recorded evaluations . The final evaluation can not be determined . Comment : Study personnel have been instructed in the manner in which observations will be recorded in order to preclude ...
Page 135
... Evaluation . 456 $ 18,042 6.0 % 5.5 % 460 $ 18,883 6.2 % 5.6 % Drug Quality Assurance . 831 28,668 10.9 % 8.8 % 797 29,238 10.8 % 8.7 % Generic Drug Standards . 114 3,778 1.5 % 1.2 % 105 3,731 1.4 % 1.1 % DESI / Generic Drug Evaluation ...
... Evaluation . 456 $ 18,042 6.0 % 5.5 % 460 $ 18,883 6.2 % 5.6 % Drug Quality Assurance . 831 28,668 10.9 % 8.8 % 797 29,238 10.8 % 8.7 % Generic Drug Standards . 114 3,778 1.5 % 1.2 % 105 3,731 1.4 % 1.1 % DESI / Generic Drug Evaluation ...
Page 138
... evaluation of individual chemicals , we consider all available studies , including epidemiology , metabolism and muta- genicity studies as well as classical animal studies . Each study is judged on its quality and relevance of the ...
... evaluation of individual chemicals , we consider all available studies , including epidemiology , metabolism and muta- genicity studies as well as classical animal studies . Each study is judged on its quality and relevance of the ...
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action activities additional aflatoxin agency agency's amended ampicillin analysis analyzed animal drugs appropriate approval approximately benzodiazepines blood budget Bureau carcinogen chemical cimetidine clinical Committee commodities compliance Conduct consumer contamination cosmetic costs determine digoxin dispensers distribution dose Drug Administration Drug Applications effects established Estimated evaluation facilities FDA's Federal Register feed Food and Drug Food Safety FSQS funds HOUSTON human implementation increase industry initial inspection investigations laboratory manufacturers meat and poultry medical devices ment methods methoxsalen million monitoring NOVITCH orphan drugs patient package inserts percent personnel pesticide petition pharmacists pharmacy phenytoin potential POULTRY PRODUCTS PPIs prescription drug problems procedures proposed radiation regulations regulatory reports request requirements response revised risk samples scientific September 12 Service SODIUM specific standards submitted testing thiazide tion toxic Toxicology USDA vaccines warfarin WHITTEN