Agriculture, rural development, and related agencies appropriations for 1982: hearings before a subcommittee of the Committee on Appropriations, House of Representatives, Ninety-seventh Congress, first session, Issue 8U.S. Government Printing Office, 1981 |
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Page 39
... notice before the product may enter the market . During that period the FDA will determine whether the device is substantially equivalent to a device on the market before the date the Amendments became law , i.e. , May 28 , 1976 or to a ...
... notice before the product may enter the market . During that period the FDA will determine whether the device is substantially equivalent to a device on the market before the date the Amendments became law , i.e. , May 28 , 1976 or to a ...
Page 88
... Notice of Proposed Rulemaking which will address this concept . This Notice will outline a policy to establish safe levels for trace carcinogenic constituents of food and color additives . We will submit a copy of this proposed policy ...
... Notice of Proposed Rulemaking which will address this concept . This Notice will outline a policy to establish safe levels for trace carcinogenic constituents of food and color additives . We will submit a copy of this proposed policy ...
Page 91
... notice of an opportunity for a hearing before the Secretary under subsection ( d ) on the question whether such application is approvable . If the applicant elects to accept the opportunity for hearing by written request within thirty ...
... notice of an opportunity for a hearing before the Secretary under subsection ( d ) on the question whether such application is approvable . If the applicant elects to accept the opportunity for hearing by written request within thirty ...
Page 92
... notice and oppor- tunity for hearing to the applicant , withdraw approval of an application with respect to any drug under this section if the Secretary finds ( 1 ) that clinical or other experience , tests , or other scientific data ...
... notice and oppor- tunity for hearing to the applicant , withdraw approval of an application with respect to any drug under this section if the Secretary finds ( 1 ) that clinical or other experience , tests , or other scientific data ...
Page 93
... notice requirements of section 510 ( j ) ( 2 ) , or the appli- cant has refused to permit access to , or copying or verifi- cation of , such records as required by paragraph ( 2 ) of such subsection ; or ( 2 ) that on the basis of new ...
... notice requirements of section 510 ( j ) ( 2 ) , or the appli- cant has refused to permit access to , or copying or verifi- cation of , such records as required by paragraph ( 2 ) of such subsection ; or ( 2 ) that on the basis of new ...
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action activities additional aflatoxin agency agency's amended ampicillin analysis analyzed animal drugs appropriate approved benzodiazepines budget Bureau business day carcinogen chemical Chicago Mercantile Exchange cimetidine clinical Committee Commodity compliance Conduct consumer contain Continue contract cosmetic costs delivery month digoxin dispensers distribution Drug Administration Drug Applications effects established Estimated evaluation FDA's Federal Register feed Food and Drug Food Safety FSQS funds grade guidelines HOUSTON human implementation increase industry initial inspection investigations labeling laboratory manufacturers meat and poultry medical devices methods methoxsalen monitoring NOVITCH orphan drugs patient package inserts percent pesticide pharmacists pharmacy phenytoin potential PPIs prescription drug Price Fluctuation problems procedures proposed regulations regulatory reports request requirements residue response revised risk samples Service SODIUM specific standards studies submitted testing thiazide tion toxic trading USDA vaccines warfarin WHITTEN