FDA Issues Final Guidance on Companion Diagnostic, LDT Draft Guidance to Follow
On July 31st, the U.S. Food and Drug Administration (FDA) notified Congress of its plans to release the long-awaited draft guidance for the regulation of laboratory developed tests (LDTs). With this notification, the FDA released a preview of the draft guidance. The Agency will formally publish its draft guidelines for public comment after 60 days. In addition, the Agency released a final guidance on the development, review, and approval of companion diagnostics.