The US Food and Drug Administration's guideline on the development of companion diagnostics is expected to be finalised by 30 June, the agency has announced in a document outlining its medical device unit's strategic priorities for 20121.
A draft version of the guideline, which covers tests that are used to tailor drug therapies to patients, was issued for stakeholder consultation last year, and indicated the FDA's intention to conduct "simultaneous reviews" of a drug/biologic therapy and its corresponding test2...
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