Publications

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Displaying 1 through 3 of 3 publications.

Comerford E, Norcross L, Sasane M, Zheng Y, Gnanasakthy A. Patient-reported outcome (PRO) data in oncology NDAs approved by the FDA (2018–2021): a review of criticism and concerns in comments from regulators. Poster presented at the National Comprehensive Cancer Network (NCCN) 2024 Annual Conference; April 5, 2024. Orlando, FL. [abstract] J Natl Compr Canc Netw. 2024 Apr 5; 22(2.5). doi: 10.6004/jnccn.2023.7146

Coombs J, McBurney C, Gondek K, Copley-Merriman C. Evidence of patient reported outcomes in labeling for oncology products: evaluation of United States and European labels. Mapi Quality of Life Newsletter. 2002 Oct;29:1-3.

Shah S, Sesti AM, Chopra T, McLaughlin-Miley C, Copley-Merriman K. Quality of life terminology documented in package inserts. Mapi Quality of Life Newsletter. 2001 Jul;27:1-3.