Guidance for new Alzheimer's treatments unveiled by FDA

02/7/2013 | Modern Healthcare (subscription required) · Hill, The · Reuters

The FDA released a nine-page draft guidance document that recommends ways to develop medicines aimed at treating Alzheimer's disease before the onset of brain damage and memory loss. "This draft guidance is intended to serve as a focus for continued discussions between the FDA and pharmaceutical sponsors, the academic community, advocacy groups, and the public," the FDA Center for Drug Evaluation and Research's Dr. Russell Katz said. The Pharmaceutical Research and Manufacturers of America has identified a lack of noninvasive, validated biomarkers and the nature of the illness itself as reasons behind statistics that show only three drugs have been approved since 1998, while 101 candidates have failed.

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Modern Healthcare (subscription required) · Hill, The · Reuters

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