Dietary supplements: uncertainties in analyses underlying FDA's proposed rule on ephedrine alkaloids : report to the Chairman and Ranking Minority Member, Committee on Science, House of Representatives
The Office, 1999 - Medical - 79 pages
10 pages matching consumption of dietary in this book
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13 aers Adverse Drug Reactions adverse events associated adverse events reported AERs in Rulemaking agency's alternative assumptions Analysis of Benefits Benefits and Costs cardiomyopathy clinical compliance concluded consumers consumption of dietary containing ephedrine alkaloids determine dietary supplement industry dietary supplement products dietary supplements containing dosing regimen Drug elements example fda identified fda noted fda officials FDA relied fda's analysis fda's cost-benefit analysis fda's estimate fda's proposed rule federal FERC final rule Human Services indirect effects initial regulatory flexibility labeling mg per serving million number of adverse number of small Office of Advocacy oira guidance point estimate prior rulemaking products containing ephedrine proposed action recommended regulatory alternatives Regulatory Flexibility Act regulatory flexibility analysis reported adverse events requires agencies result risk sba's Office scientific literature serious adverse events Small Business Administration small entities specific dosing level sulfiting agents supplements containing ephedrine tartrazine transparency uncertainty