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 34
... application to 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 ...
... application to 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 ...
Page 39
... application containing evidence that the device is safe and effective before it can be made available to the public ... application , FDA notifies the applicant in writing that the application is , or is not , accepted for review . If ...
... application containing evidence that the device is safe and effective before it can be made available to the public ... application , FDA notifies the applicant in writing that the application is , or is not , accepted for review . If ...
Page 42
... applying current technology in such areas as instrumentation , facilities and computerization ; as well as to new ... application of resources . Some firms have abandoned research on new drugs in favor of roles as generic drug or OTC ...
... applying current technology in such areas as instrumentation , facilities and computerization ; as well as to new ... application of resources . Some firms have abandoned research on new drugs in favor of roles as generic drug or OTC ...
Page 88
... application in this country , but rather a simple assumption that approval in a foreign country should be defined as approval in the United States . If there are statutory restrictions , please cite the statutes and submit copies of the ...
... application in this country , but rather a simple assumption that approval in a foreign country should be defined as approval in the United States . If there are statutory restrictions , please cite the statutes and submit copies of the ...
Page 90
... application filed pursuant to subsection ( b ) is effective with respect to such drug . ( b ) Any person may file with the Secretary an appli- cation with respect to any drug subject to the provisions of subsection ( a ) . Such persons ...
... application filed pursuant to subsection ( b ) is effective with respect to such drug . ( b ) Any person may file with the Secretary an appli- cation with respect to any drug subject to the provisions of subsection ( a ) . Such persons ...
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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