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Patient-reported outcome (PRO) data in oncology NDAs approved by the FDA (2018–2021)
A review of criticism and concerns in comments from regulators
Comerford, E., Norcross, L., Sasane, M., Zheng, Y., & Gnanasakthy, A. (2024). Patient-reported outcome (PRO) data in oncology NDAs approved by the FDA (2018–2021): A review of criticism and concerns in comments from regulators. Journal of the National Comprehensive Cancer Network : JNCCN, 22(2.5), Article HSR24-152. https://doi.org/10.6004/jnccn.2023.7146
