FDA Companion, Co-Development Dx Guidances On Track, Official Says

FDA aims to issue both a final companion diagnostics guidance document and a separate draft guidance on the co-development of drugs and tests in the coming months.

FDA hopes to issue a draft guidance on co-development of drugs and diagnostics by “late summer,” according to Elizabeth Mansfield, the top personalized medicine official at CDRH.

The planned guidance is a follow-up effort to draft guidelines released last July providing FDA’s definition of a companion diagnostic and outlining policies for approval and labeling of therapeutic/diagnostic pairs....

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