James Boiani Quoted in “FDA IVD Codevelopment Guide Seen as Step Toward Consistent Reviews”

FDA Week and Inside Health Policy

James A. Boiani, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in FDA Week and Inside Health Policy, in “FDA IVD Codevelopment Guide Seen as Step Toward Consistent Reviews,” by Nicholas Florko. (Read the full version – subscription required.)

Following is an excerpt:

One attorney who represents device manufacturers said policies have been inconsistent among FDA reviewers, both within review centers and across centers. There has been ambiguity around FDA expectations about developing drugs and diagnostics together, explained James A. Boiani, a member of the law firm Epstein Becker & Green.

Boiani sees the new guidance as a meaningful step toward achieving consistency across FDA. “Getting all three Centers to sign on to the guidance is a big deal, in my opinion,” wrote Boiani in an emailed statement to Inside Health Policy. “It will help develop internal consistency, and a baseline approach that will apply, within and across the Centers.”