FDA Genomics Guidance Paves Way For PKG Firms; Genaissance May Benefit
Executive Summary
Genaissance Pharmaceuticals is developing a pharmacogenomics-based assay for predicting an individual occurrence of agranulocytosis associated with the antipsychotic clozapine (Novartis' Clozaril and generics)
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FDA public workshop to discuss a draft guidance on the co-development of pharmacogenomics tests with a drug or biologic is planned for April 11-13, 2005 in Bethesda, Md. The draft guidance is expected by the end of the year. The agency published a draft guidance on pharmacogenomics data submissions in November 2003 (1"The Pink Sheet" Nov. 10, 2003, p. 11)...
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FDA public workshop to discuss a draft guidance on the co-development of pharmacogenomics tests with a drug or biologic is planned for April 11-13, 2005 in Bethesda, Md. The draft guidance is expected by the end of the year. The agency published a draft guidance on pharmacogenomics data submissions in November 2003 (1"The Pink Sheet" Nov. 10, 2003, p. 11)...
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