FDA proposes companion Dx guidelines

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The FDA has proposed new rules for the review of companion diagnostics--tests designed to identify patients most likely to respond to a drug, or predict unfavorable side effects. Companion diagnostics are increasingly attractive to drug developers because the pairings can help healthcare providers improve outcomes for certain patients while saving time, money and potentially serious side effects by withholding treatment from those who are unlikely to respond to the therapy.

The FDA's proposal recommends early engagement between the FDA and developers; it explains the agency's plan to simultaneously review therapies and companion diagnostics. The proposal also outlines instances in which the regulator may approve a medicine without a companion test. Therapies for serious illnesses that have no other available treatment may receive priority review, with the companion diagnostic approved later. The FDA is soliciting comments on the draft guidance for 60 days.

"These proposed guidelines support the development of innovative new targeted medicines and their corresponding diagnostic tests and are intended to provide manufacturers with greater predictability," said CDRH director Jeffrey Shuren in a statement. "It is the agency's goal to help stimulate early collaborations between drug and device makers so they can develop the best medical products for treating patients."

- here's the FDA release
- read the Reuters article

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