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
Bui CL, Kaye JA, Castellsague J, Calingaert B, McQuay LJ, Riera-Guardia N, Saltus CW, Quinlan SC, Holick CN, Wahl PM, Suzart K, Rothman KJ, Wallander MA, Perez-Gutthann S. Validation of acute liver injury cases in a population-based cohort study of oral antimicrobial users. Curr Drug Saf. 2014 Mar;9(1):23-8.
McAfee AT, Holdridge KC, Johannes CB, Hornbuckle K, Walker AM. The effect of pharmacotherapy for attention deficit hyperactivity disorder on risk of seizures in pediatric patients as assessed in an insurance claims database. Curr Drug Saf. 2008 May 1;3(2):123-31.