Collecting Foreign Data? Come Talk To Us, FDA Says :: “The Gray Sheet” :: Pharma & Medtech Business Intelligence

Collecting Foreign Data? Come Talk To Us, FDA Says :: “The Gray Sheet” :: Pharma & Medtech Business Intelligence: "FDA has been accepting data from patients outside of the U.S. to support device approvals for years, but the sponsor should check with the agency in advance to ensure the foreign data meets the needs of the U.S. regulatory system, according to a new draft guidance. "