Guest guest Posted February 18, 2008 Report Share Posted February 18, 2008 In the recent news conference regarding FDA's decision on bio-identical compounded drugs they state that there is no evidence that estriol is safe. " Steve Silverman: " We lack data demonstrating safety and efficacy. " They did not mention it but their claims that such is the case leads me to believe that they rely on NGC and/or data from firms seeking drug approval. Drug approval for a new drug involves years and years of red tape and is excessively onerous. http://www.guideline.gov/browse/guideline_index.aspx for all their informaton. NGC states that they are not the final authority however apparently the FDA does not really believe that and apparently bases their decisions on information gleaned from NGC. Doing a search at NGC comes up with no information about Estriol although four hits did materialize but none of them have any information about Estriol. A search at Medline elicited ALMOST 7000 hits and I wonder if the FDA even uses Medline or they even know about it. The North American Menopause Society is big contributor to information at NGC and their guidelines do not include products from compounding pharmacies. Wyeth is one of NAM'S r big contributors and half of NAMS’s Board of Trustees for 2007-2008 receive money from Wyeth. Dr. Wulf Utian, executive director of NAMS, on Larry King Live stated he is not funded by Wyeth however His declaration is patently false. http://www.compoundingfacts.org/info.cfm?News_ID=93 Ora Quote Link to comment Share on other sites More sharing options...
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