AdvaMedDx Challenges Oncology Test Pilot

AdvaMedDx says an FDA 6/22 guidance on a pilot program for oncology drug products used with certain in vitro tests would have benefited from advance notice and opportunity to comment. The association’s 9/28 comment letter says FDA issued the pilot as an immediately-in-effect guidance, thus missing an opportunity for “broad engagement with industry and key stakeholders to communicate proactively about, and incorporate feedback into, this program.” The letter says such feedback could have helped identify concerns and considerations that limit the ability of the pilot to achieve its stated objectives in its current form.

AdvaMedDx also lists many questions for FDA related to the initial test, the minimum performance characteristics test, and the evaluation of the program. “We encourage FDA to publicly outline its thinking regarding these key questions,” the letter concludes.