NCCS comments on FDA’s draft guidance for in vitro companion diagnostic devices
NCCS filed comments on the Food and Drug Administration’s Draft Guidance for Industry and Food and Drug Administration Staff: In Vitro Companion Diagnostic Devices on October 12, 2011.
The Draft sets out a proposed framework for drug and test makers to use in developing targeted treatments and new tests to help identify patients most likely to benefit from a given treatment. NCCS expresses support for much of the process proposed by the FDA. However, our comments also highlights areas where additional clarity would be helpful to industry as well as to agency staff in order to ensure that tests will be useful for patients and their doctors in making treatment decisions.