Van Vo, Anthony Harrington, Ching-Lan Chang, Hayley Baker, Michael A Moshi, Nabih Ghani, Jose Yani Itorralba, Richard L Tillett, Elizabeth Dahlmann, Natnael Basazinew, Richard Gu, Tiffany D Familara, Sage Boss, Fritz Vanderford, Moonis Ghani, Austin J Tang, Alice Matthews, Katerina Papp, Eakalak Khan, Carolina Koutras, Horng-Yuan Kan, Cassius Lockett, Daniel Gerrity, Edwin C Oh
Identification and genome sequencing of an influenza H3N2 variant in wastewater from elementary schools during a surge of influenza A cases in Las Vegas, Nevada
The Science of the total environment
recent benefitrisk framework brf developed food drug administration fda intended improve clarity consistency communicating reasoning behind fdas decisions acting important advancement us drug regulation pdufa vi implementation plan fda states continue explore structured quantitative decision analysis approaches however restricts use within current brf purely qualitative contrast european regulators researchers long exploring use quantitative decision analysis approaches evaluating drug benefitrisk balance paper show quantitative modelling backed decision theory could complement extend fdas brf better support appraisal evidence improve decision outcomes providing relevant scientific definitions benefitrisk assessment describing fda european medicines agency ema frameworks explain components differences qualitative quantitative approaches present lessons learned ema experience use quantitative modelling provide evidence benefits illustrated real case study helped resolve differences judgements among ema regulators