FDA estrogen guidance
Agency will hold a meeting in December concerning hormone therapy draft guidance revisions. FDA may release a revised guidance in 2006 including methods for determining the lowest effective dose in estrogen replacement drug products. Agency will revise guidance to refine changes resulting from safety signals in the NIH Women's Health Initiative hormone therapy trial (1"The Pink Sheet" May 16, 2005, p. 21)...
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FDA will make significant changes to a 2003 FDL-1draft guidance on estrogen products and reissue a new draft
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