ABBREVIATIONS

ANDA Abbreviated New Drug Application ASR annual study report BCPNN Bayesian confidence propagation neural network BLA Biologics License Application cGCP current Good Clinical Practice cGLP current Good Laboratory Practice cGMP current Good Manufacturing Practice CBA cost-benefit analysis CCDS company core data sheet CEA cost-effectiveness analysis CHMP Committee for Medicinal Products for Human Use CSR clinical study report DDMAC Division of Drug Marketing, Advertising and Communication (FDA) EU-RMP European Union-Risk Management Plan GvHD graft-versus-host disease GPS&RM Global Patient Safety & Risk Management ICH International Conference on Harmonisation IDE Investigational Device Exemption IND Investigational New Drug ISE Integrated Summary of Efficacy ISS Integrated Summary of Safety MedDRA Medical Dictionary for Regulatory Activities MGPS multi-item gamma Poisson Shrinker PADER Periodic Adverse Drug Experience Report PLA Product License Application PLR Physicians’ Labeling Rule PMA Pre-Market Approval (application) PRR proportional reporting ratio PSUR Periodic Safety Update Report REMS Risk Evaluation and Mitigation Strategy RiskMAP Risk Minimization Action Plan SAE serious adverse event sBLA supplemental Biologics License Application sNDA supplemental New Drug Application SPL Structured Product Labeling (FDA) SUSAR suspected unexpected serious adverse reaction (EMA) UADE unanticipated adverse device effect

XXX used once in document YYY used twice in document ZZZ used thrice in document