FDA May Issue More White Papers on Rx/Dx Codevelopment, Woodcock Says At Meeting | GenomeWeb

The US Food and Drug Administration may issue a series of white papers outlining the most up-to-date knowledge on drug/diagnostic codevelopment, a top agency official said at a recent conference.

Since the FDA issued its first white paper on Rx/Dx codevelopment in 2005, the agency's understanding of the issues involved has "significantly increased," said Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, at the "FDA-Industry IVD/Companion Diagnostic Drug Roundtable" in Washington, DC, last month.

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