[全球医生组织北京代表处]|资讯|“人民的希望”瑞德西韦正式获FDA紧急授权应用( 二 ) 5月1日

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可能的不良反应
Possiblesideeffectsofremdesivirinclude:increasedlevelsofliverenzymes,whichmaybeasignofinflammationordamagetocellsintheliver;andinfusion-relatedreactions,whichmayincludelowbloodpressure,nausea,vomiting,sweating,andshivering.
FollowingthedeclarationbytheSecretaryofHHSthatcircumstancesexistjustifyingtheemergencyuseofunapprovedproducts,theFDAmayissueanemergencyuseauthorizationtoallowunapprovedmedicalproductsorunapprovedusesofapprovedmedicalproductstobeusedinanemergencytodiagnose,treat,orpreventseriousorlife-threateningdiseasesorconditionscausedbychemical,biological,radiologicalandnuclearthreatswhentherearenoadequate,approved,andavailablealternatives.
TheissuanceofanEUAisdifferentthanFDAapproval.IndeterminingwhethertoissueanEUA,theFDAevaluatestheavailableevidenceandcarefullybalancesanyknownorpotentialrisksofanyunprovenproductswithanyknownorpotentialbenefitsofmakingthemavailableduringtheemergency.
TheEUAwasissuedtoGileadSciencesInc.TheFDApreviouslyallowedforstudyoftheinvestigationaldrugunderclinicaltrials,aswellasexpandedaccessuseforindividualpatientsandthroughamulti-patientexpandedaccessprogramcoordinatedbyGilead.
TheEUAwillbeeffectiveuntilthedeclarationthatcircumstancesexistjustifyingtheauthorizationoftheemergencyuseofdrugsandbiologicsforpreventionandtreatmentofCOVID-19isterminatedandmayberevisedorrevokedifitisdeterminedtheEUAnolongermeetsthestatutorycriteriaforissuance.
TheFDA,anagencywithintheU.S.DepartmentofHealthandHumanServices,protectsthepublichealthbyassuringthesafety,effectiveness,andsecurityofhumanandveterinarydrugs,vaccinesandotherbiologicalproductsforhumanuse,andmedicaldevices.
Theagencyalsoisresponsibleforthesafetyandsecurityofournation’sfoodsupply,cosmetics,dietarysupplements,productsthatgiveoffelectronicradiation,andforregulatingtobaccoproducts.
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【[全球医生组织北京代表处]|资讯|“人民的希望”瑞德西韦正式获FDA紧急授权应用】祈祷·光明

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