PGx: Back to the Drawing Board

FDAand key members of Congress have decided the agency's current policies aren't sufficient to ensure the safety and efficacy of pharmacogenomic diagnostics, so they have launched separate efforts to expand FDA's oversight of the field.

The legislative and administrative efforts are in their early stages, which may allow test developers, clinical laboratories, drug companies pursuing products coupled with companion diagnostics, and the medical community to shape the future regulatory environment...