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
... APPROVAL Mr. WHITTEN . Doctor , we are glad to have your statement . This committee has had some views on FDA's responsibilities , and we have been impressed from time to time as laymen and private citizens . None of us on the committee ...
... APPROVAL Mr. WHITTEN . Doctor , we are glad to have your statement . This committee has had some views on FDA's responsibilities , and we have been impressed from time to time as laymen and private citizens . None of us on the committee ...
Page 20
... really think that we are working systematically toward it . Mrs. SMITH . While you are on this subject , Mr. Chairman , ask a question ? may I REQUIREMENTS FOR DRUG APPROVAL Mrs. SMITH . I am also Mr. WHITTEN . Certainly , Mrs. Smith . 20.
... really think that we are working systematically toward it . Mrs. SMITH . While you are on this subject , Mr. Chairman , ask a question ? may I REQUIREMENTS FOR DRUG APPROVAL Mrs. SMITH . I am also Mr. WHITTEN . Certainly , Mrs. Smith . 20.
Page 27
... APPROVAL PROCESS Two related issues are relevant to the Agriculture Appropri- ations Subcommittee's consideration of the FDA appropriations for the next fiscal year . Both issues are illustrated by the FDA's han- dling of Newport ...
... APPROVAL PROCESS Two related issues are relevant to the Agriculture Appropri- ations Subcommittee's consideration of the FDA appropriations for the next fiscal year . Both issues are illustrated by the FDA's han- dling of Newport ...
Page 33
... approve a drug whose side effects are worse than its benefits , or which is actually ineffective . Sometimes it turns out ... approval is affected by four factors . One , the intrinsic pharmacologic properties of the drug - an unsafe or ...
... approve a drug whose side effects are worse than its benefits , or which is actually ineffective . Sometimes it turns out ... approval is affected by four factors . One , the intrinsic pharmacologic properties of the drug - an unsafe or ...
Page 34
... approval is decreasing . In calendar year 1980 FDA approved 114 new drug applications . The mean time from NDA receipt to approval was 21.3 months . This represents the total time , including sponsor time for replies . However , we will ...
... approval is decreasing . In calendar year 1980 FDA approved 114 new drug applications . The mean time from NDA receipt to approval was 21.3 months . This represents the total time , including sponsor time for replies . However , we will ...
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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