FDA Issues Final Guidance on Patient-reported Outcome Measures Used to Support Labeling Claims

Alan G. Minsk, Jennifer S. Blakely and Diana Rusk Cohen authored an article for the April 2010 edition of the Regulatory Affairs Professionals Society’s Regulatory Focus magazine. The article is titled, “FDA Issues Final Guidance on Patient-reported Outcome Measures Used to Support Labeling Claims.” In December 2009, the U.S. Food and Drug Administration (FDA) issued Guidance for Industry: Patient-reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. While the guidance is not legally binding and does not offer clear answers, it provides manufacturers with some insight into how the FDA evaluates patient-reported outcome (PRO) instruments that manufacturers use to support claims on medical product labels and the data the instruments yield. The article analyzes how the guidance can help healthcare product companies use PRO instruments to substantiate quality of life labeling claims. Please click here to read the full article.