As
of Summer 2010, we have held 4 meetings with the FDA, the most
recent with the PRO Consortium. There are ongoing discussions
regarding the acceptability of PROMIS measures and a broader,
shared regulatory science agenda. Laurie Burke, MPH, PRh,
Director of Study Endpoint and Label Development at the Center for
Drug Evaluation and Research at the FDA stated, “FDA joins NIH in
the goal of ensuring that PROMIS results in meaningful measurement
of the impact of medical product treatment.” At the end of the day,
the best way to get a read from the FDA on PROMIS is to include it
with a submission for consideration.
