Stakeholders: Codevelopment Guide Lacks Clarity On Complementary Dx

Stakeholders say FDA's July 15 draft guidance on codevelopment of an in vitro diagnostic with a therapeutic is an important step for advancing personalized medicine, but argue it is crucial the agency also clarify its intentions regarding a new product category called complementary diagnostics. FDA's assertion that principles in the July guidance may be relevant to diagnostics that do "not meet the definition of a CoDx but are 'nonetheless beneficial for therapeutic product development or clinical decision making"' raised concerns...