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 16
... testing and approval of new drugs . It was concluded that it will be a long and arduous effort to achieve the goal of an international NDA that could be submitted to , and reviewed simultaneously by , a number of countries , but a ...
... testing and approval of new drugs . It was concluded that it will be a long and arduous effort to achieve the goal of an international NDA that could be submitted to , and reviewed simultaneously by , a number of countries , but a ...
Page 39
... testing . FDA is developing case studies profiling the ex- penditures on testing and clinical trials by selected device firms prior to the passage of the 1976 Device Amendments to obtain a range of costs . Mr. LEWIS . Mr. Chairman , you ...
... testing . FDA is developing case studies profiling the ex- penditures on testing and clinical trials by selected device firms prior to the passage of the 1976 Device Amendments to obtain a range of costs . Mr. LEWIS . Mr. Chairman , you ...
Page 92
... tests by new methods , or tests by methods not deemed reasonably ap- plicable when such application was approved , evaluated together with the evidence available to the Secretary when the application was approved , shows that such drug ...
... tests by new methods , or tests by methods not deemed reasonably ap- plicable when such application was approved , evaluated together with the evidence available to the Secretary when the application was approved , shows that such drug ...
Page 94
... testing of a new drug is undertaken , of re- ports , by the manufacturer or the sponsor of the in- vestigation of such drug , or preclinical tests ( includ ing tests on animals ) of such drug adequate to jus- tify the proposed clinical ...
... testing of a new drug is undertaken , of re- ports , by the manufacturer or the sponsor of the in- vestigation of such drug , or preclinical tests ( includ ing tests on animals ) of such drug adequate to jus- tify the proposed clinical ...
Page 100
... testing , such as toxicology work , has already been accomplished and , consequently , may not need to be repeated . There are no set costs which can be factored into an equation or algorithm to determine the total development costs of ...
... testing , such as toxicology work , has already been accomplished and , consequently , may not need to be repeated . There are no set costs which can be factored into an equation or algorithm to determine the total development costs of ...
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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