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Witnesses Voice Support For Biologic Pathway

Law360 (March 26, 2007, 12:00 AM EDT) -- A number of drug makers and the Food and Drug Administration told lawmakers Monday that the agency has the ability to evaluate at least some generic or follow-on biologic products.

Dr. Janet Woodcock, the deputy commissioner and chief medical officer with the FDA, said that some biologic products would be simpler than others to evaluate.

"The ability to predict the clinical comparability of two products depends on our understanding of the relationship between the structural characteristics of the protein and its function, as well as on...
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