#remdesivir #gilead #amgen #genentech #vir #modern #covid-19vaccine #cder #maa. #cber #nda #cta #ind #compassionateuse #eau #fdactap #emacoronavirus #emacovid-19 #fdacoronavirus #fdacovid-19 #coronovirusglobalregulatorypathways #covid-19globalregulatorypathways #coronovirusregulatorypathways #coronavirusvaccines. #covid-19regulatorypathways #coronavirustherapies #covid-19 expedited regulatory pathways fda guidance gene therapy racglobal raps globalregulatoryaffairs ema european medicines agency pmda fda unmetmedicalneed generegulatoryaffairs regulatorypathways fasttrackdeignation rmatregulatoryaffairs rmat regenerativemedicine raredisease regulatoryaffairsgenetherapy regulatoryaffairs genetherapy munish <manrao@epcits.com> anna pratskevich <anyapratskevich@gmail.com> rock <rockzhangus@gmail.com> noel gonzalez <noelgnuke@gmail.com> mridula shukla <mridulashukla22@gmail.com>
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