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 36
... proposed revision of the IND regulations to be published in the spring of 1982 . Two specific regulatory reforms ... proposed ? Dr. NOVITCH . FDA has told Newport that it will accept historical data regarding Isoprinosine . Mr. WHITTEN ...
... proposed revision of the IND regulations to be published in the spring of 1982 . Two specific regulatory reforms ... proposed ? Dr. NOVITCH . FDA has told Newport that it will accept historical data regarding Isoprinosine . Mr. WHITTEN ...
Page 128
... proposed organization's type or form . The Study Group members could see both merits and defects in either an informal advisory / ccordinating body or a formally estalbished government unit . The issue on which members particularly ...
... proposed organization's type or form . The Study Group members could see both merits and defects in either an informal advisory / ccordinating body or a formally estalbished government unit . The issue on which members particularly ...
Page 164
... Proposed Regulations FDA proposed patient package inserts requirements under which the manufacturer of a drug product would be responsible for preparing and distributing patient package inserts written in non - technical language . The ...
... Proposed Regulations FDA proposed patient package inserts requirements under which the manufacturer of a drug product would be responsible for preparing and distributing patient package inserts written in non - technical language . The ...
Page 165
... proposed regulations . Some comments argued that these deficiencies warranted ending the rulemaking , while others suggested that the deficiencies indicated a need for further studies to assess more accurately the regulations ' costs ...
... proposed regulations . Some comments argued that these deficiencies warranted ending the rulemaking , while others suggested that the deficiencies indicated a need for further studies to assess more accurately the regulations ' costs ...
Page 166
... proposal ( 44 FR 40031 ; July 6 , 1979 ) for the agency's program to study further the effects of patient package ... proposed regulations is misplaced because those provisions were intended to apply only to affirmative statements a ...
... proposal ( 44 FR 40031 ; July 6 , 1979 ) for the agency's program to study further the effects of patient package ... proposed regulations is misplaced because those provisions were intended to apply only to affirmative statements a ...
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Common terms and phrases
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