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FDA drafts guidance on targeted medicines, tests
Modern Healthcare

The Food and Drug Administration issued a draft guidance that proposes targeted medicines be reviewed in conjunction with their corresponding diagnostic tests.

In addition, the guidance document provides information about how the FDA defines a “companion diagnostic” device, how such therapeutic products and their companion devices should be labeled, and instances when it may approve a targeted medicine even if the companion diagnostic test has not yet been approved or cleared, such as in the case of a serious or life-threatening condition.