FDA IVD Codevelopment Guide Seen As Step Toward Consistent Reviews

July 22, 2016
New FDA guidance outlining steps for codevelopment of in vitro companion (IVD) diagnostic devices drew praise from industry sources for its emphasis on open communication among sponsors and agency centers. A device industry attorney said the guidance is a meaningful step toward achieving consistency across FDA centers, and another source said it shows FDA's centers plan to work together in a meaningful way. The document is described by FDA as a “practical guide” on how therapeutic product and IVD sponsors...

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