FDA Pilots Program for Oncology Treatments, Diagnostic Tests (1)

The Food and Drug Administration has launched a pilot program for oncology drug products used with certain in vitro diagnostic tests to help physicians choose appropriate cancer treatments, according to the FDA Tuesday.

The voluntary pilot program will allow the FDA to request performance information for the tests used to enroll patients into the clinical trials that support drug approval, said the agency. The FDA will then post to its website the minimum performance characteristics recommended for similar tests that may be used to select patients for treatment with the approved drug.

Laboratories will then be able to use ...