FDA Measures Supplement Firms' GMP Recordkeeping Burden
This article was originally published in The Tan Sheet
Executive Summary
FDA will gauge how firms handle one of the most important and difficult aspects of compliance with dietary supplement good manufacturing practices - recordkeeping
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GMP recordkeeping estimate to OMB
FDA submits its estimate of 929,140 annual hours for the dietary supplement industry's total recordkeeping burden under good manufacturing practice regulations to the Office of Management and Budget. A Sept. 27 Federal Register notice explains OMB will review FDA's estimate for clearance. The agency received no comments on its estimate posted in July (1"The Tan Sheet" July 19, 2010)
GMP recordkeeping estimate to OMB
FDA submits its estimate of 929,140 annual hours for the dietary supplement industry's total recordkeeping burden under good manufacturing practice regulations to the Office of Management and Budget. A Sept. 27 Federal Register notice explains OMB will review FDA's estimate for clearance. The agency received no comments on its estimate posted in July (1"The Tan Sheet" July 19, 2010)
GMP recordkeeping estimate to OMB
FDA submits its estimate of 929,140 annual hours for the dietary supplement industry's total recordkeeping burden under good manufacturing practice regulations to the Office of Management and Budget. A Sept. 27 Federal Register notice explains OMB will review FDA's estimate for clearance. The agency received no comments on its estimate posted in July (1"The Tan Sheet" July 19, 2010)