FDA’s GMP Recall Cost Savings Estimates Too High, CRN Says
This article was originally published in The Tan Sheet
Executive Summary
Savings from avoiding illnesses caused by recalled dietary supplement products would be significantly less than FDA projects for its proposed supplement good manufacturing practices rule, the Council for Responsible Nutrition estimates
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OMB’s GMP edits
Dietary supplement GMP draft proposal's description of "uncertainties in the analysis" of the cost and benefits of the rule beefed up by the agency following pre-publication review by the OMB Office of Information & Regulatory Affairs. More than two pages outlining health benefit assumptions added to final Federal Register version. Industry groups have criticized the analysis as overestimating the benefits and underestimating the cost of the proposed GMPs (1"The Tan Sheet" Sept. 15, 2003, p. 13). FDA recently released the marked up version of the draft proposal in observation of Executive Order 12866 requirements for disclosure regarding "significant regulatory actions"...
OMB’s GMP edits
Dietary supplement GMP draft proposal's description of "uncertainties in the analysis" of the cost and benefits of the rule beefed up by the agency following pre-publication review by the OMB Office of Information & Regulatory Affairs. More than two pages outlining health benefit assumptions added to final Federal Register version. Industry groups have criticized the analysis as overestimating the benefits and underestimating the cost of the proposed GMPs (1"The Tan Sheet" Sept. 15, 2003, p. 13). FDA recently released the marked up version of the draft proposal in observation of Executive Order 12866 requirements for disclosure regarding "significant regulatory actions"...
OMB’s GMP edits
Dietary supplement GMP draft proposal's description of "uncertainties in the analysis" of the cost and benefits of the rule beefed up by the agency following pre-publication review by the OMB Office of Information & Regulatory Affairs. More than two pages outlining health benefit assumptions added to final Federal Register version. Industry groups have criticized the analysis as overestimating the benefits and underestimating the cost of the proposed GMPs (1"The Tan Sheet" Sept. 15, 2003, p. 13). FDA recently released the marked up version of the draft proposal in observation of Executive Order 12866 requirements for disclosure regarding "significant regulatory actions"...