FDA Companion Dx Draft Guidance: Broad In Scope, Limited In Detail

Article preview from "The Gray Sheet"- July 18, 2011

FDA's draft guidance on the development of companion diagnostics for drug therapies, released July 12, delivers on a promise to publicly outline how it will address review of those products, but at only 12 pages, it has left some in industry longing for more insight.

FDA Companion Dx Draft Guidance: Broad In Scope, Limited In Detail

Article preview from "The Gray Sheet"- July 18, 2011

The agency strayed from a more ambitious concept paper on the prospective co-development of drugs and diagnostics released in 2005, a document that ran a far lengthier 37 pages. That document was criticized by industry for being too prescriptive and overly focused on an idealized, perfectly parallel approach to drug/test co-development.

In the new draft guidance, the agency is likely looking to maintain a more flexible pathway, especially as it gains more experience with companion diagnostics. The draft defines in vitro companion diagnostic devices and lays out basic expectations for the simultaneous development and regulatory review of drugs and tests, with an emphasis on collaboration between the different FDA centers.

Thus far, the agency has been working with sponsors of drug/test combinations on a case-by-case basis, and based on the initial guidance document, it appears likely to continue to do so.

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