[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 )


[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
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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.
新版《医学影像中人工智能》(369页)概述了医学影像中AI应用 , 解析了AI技术对医学的影响 , 诸如深度学习等;成像生物标记物AI应用程序开发和验证;大数据在影像学中的重要作用 。 重点介绍了AI对影像学和影像科、放射科医生的影响 。 该书是放射科医生、物理师 , IT专家和影像信息人员参考
【[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
[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
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