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 56
... final report for this completed study . The manuscript covering the outcome of this study , which is dated 8/1/80 , does not include the elements required by the GLP regulations . Comment : We have decided that the manuscript will be ...
... final report for this completed study . The manuscript covering the outcome of this study , which is dated 8/1/80 , does not include the elements required by the GLP regulations . Comment : We have decided that the manuscript will be ...
Page 84
... final report and storage of all specimens and raw data ; however , written SOP's were not maintained by each study director to cover all phases of a study . Comment : The responsibility for writing SOP's is decentralized in the Bureau ...
... final report and storage of all specimens and raw data ; however , written SOP's were not maintained by each study director to cover all phases of a study . Comment : The responsibility for writing SOP's is decentralized in the Bureau ...
Page 110
... final policy that developed was that of treating drugs of known useful- ness and not completely researched drugs of predicted usefulness essentially as interchangeable within the term " drugs of limited commercial value . " Part II ...
... final policy that developed was that of treating drugs of known useful- ness and not completely researched drugs of predicted usefulness essentially as interchangeable within the term " drugs of limited commercial value . " Part II ...
Page 160
... Final Regulation , which I will submit for the record . Very little of the cost of PPIs derives from their drafting . The major costs are associated with their distribution . Comments on the proposed regulations disputed FDA's cost ...
... Final Regulation , which I will submit for the record . Very little of the cost of PPIs derives from their drafting . The major costs are associated with their distribution . Comments on the proposed regulations disputed FDA's cost ...
Page 161
... Final Regulation , which I will submit for the record . Very little of the cost of PPIs derives from their drafting . The major costs are associated with their distribution . Comments on the proposed regulations disputed FDA's cost ...
... Final Regulation , which I will submit for the record . Very little of the cost of PPIs derives from their drafting . The major costs are associated with their distribution . Comments on the proposed regulations disputed FDA's cost ...
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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