FDA IVD Codevelopment Guide Seen As Step Toward Consistent Reviews

July 22, 2016 at 2:17 PM
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...


Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.