Mordin MM, Clark M, Siersma CA, Copley-Merriman K, Gnanasakthy A. Impact of the FDA draft guidance on patient reported outcomes (PRO) label claims for approved drug products in the US: has it made a difference? Poster presented at the International Society for Pharmacoeconomics and Outcomes Research 14th Annual International Meeting; May 19, 2009. Orlando, FL. [abstract] Value Health. 2009 May; 12(3):A29.
Clark MJ. Obtaining a patient reported outcome label claim: what is it, how do you achieve it, and why is it helpful for a pharmaceutical company? Presented at the Patient Reported Outcomes graduate course at the University of Michigan College of Pharmacy; March 1, 2009.