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This article was originally published in The Tan Sheet
Executive Summary
FDA's proposed reg "withdrawn by agency" Feb. 1, according to OMB Web site. Long-awaited reg, which was sent to OMB in November, is one of many rulemakings affected by Bush Administration memorandum stating no proposed or final regs at OMB should be sent to Office of Federal Register until "a department or agency head" appointed by President Bush "reviews and approves the regulatory action" (1"The Tan Sheet" Jan. 29, p. 3)
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Proposed reg could face another long delay as it undergoes reexamination by FDA/HHS under Bush Administration following withdrawal from OMB Feb. 1 (1"The Tan Sheet" Feb. 5, In Brief). Reg may have to wait for new FDA commissioner and likely would be an issue at confirmation hearings, industry sources speculate. Last acting commissioner served approximately 20 months
Supplement GMPs
Proposed reg could face another long delay as it undergoes reexamination by FDA/HHS under Bush Administration following withdrawal from OMB Feb. 1 (1"The Tan Sheet" Feb. 5, In Brief). Reg may have to wait for new FDA commissioner and likely would be an issue at confirmation hearings, industry sources speculate. Last acting commissioner served approximately 20 months
Supplement GMPs
Proposed reg could face another long delay as it undergoes reexamination by FDA/HHS under Bush Administration following withdrawal from OMB Feb. 1 (1"The Tan Sheet" Feb. 5, In Brief). Reg may have to wait for new FDA commissioner and likely would be an issue at confirmation hearings, industry sources speculate. Last acting commissioner served approximately 20 months