User:Mwessmd

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