医药产品紧急使用授权(Emergency Use Authorization,EUA)指由美国食品药品管理局(FDA)在实际的或潜在的紧急状态下对未获批准的医药产品的使用及已获批准产品的未获批准用途的授权。本文结合实际操作层面,对EUA的法律基础、EUA在FDA使...医药产品紧急使用授权(Emergency Use Authorization,EUA)指由美国食品药品管理局(FDA)在实际的或潜在的紧急状态下对未获批准的医药产品的使用及已获批准产品的未获批准用途的授权。本文结合实际操作层面,对EUA的法律基础、EUA在FDA使命范围内的作用、EUA的审评、发布和终止程序、应对2009年H1N1流感取得的成功经验以及EUA实施过程中遇到的挑战进行分析。同时与日本应对2009年H1N1大流行时对ArepanrixTMA/H1N1流感疫苗和Novartis H1N1流感疫苗的紧急授权进行比较分析。展开更多
BACKGROUND Colorectal cancer(CRC)could seriously threaten the physical and mental health of pilots.Shall they end their flying after treatment of CRC?With this study,we investigated the possibility of a gradual medica...BACKGROUND Colorectal cancer(CRC)could seriously threaten the physical and mental health of pilots.Shall they end their flying after treatment of CRC?With this study,we investigated the possibility of a gradual medical waiver for such pilots to fly aircrafts again after treatment of CRC.CASE SUMMARY We analyzed the medical waiver and clinical data of 3 pilots with CRC,who had accepted the treatment at the Department of General Surgery,Air Force Medical Center(formerly,Air Force General Hospital)between 2013 and 2018.All 3 cases underwent a series of comprehensive treatment courses,including radical resection of CRC,sequential radiotherapy,and chemotherapy.The follow-up results were satisfactory.After passing through the high-risk period of recurrence and metastasis of CRC,they all were given a medical waiver for flying again.Medical observation showed that their flying operations were safe.CONCLUSION The CRC treatment shall follow the guidelines for diagnosis and treatment and should simultaneously protect the combating capabilities of pilots as much as possible.It is safe for pilots with CRC,who are continuously monitored under medical observation after passing through the high-risk period of recurrence and metastasis,to undertake military flight missions again.展开更多
文摘医药产品紧急使用授权(Emergency Use Authorization,EUA)指由美国食品药品管理局(FDA)在实际的或潜在的紧急状态下对未获批准的医药产品的使用及已获批准产品的未获批准用途的授权。本文结合实际操作层面,对EUA的法律基础、EUA在FDA使命范围内的作用、EUA的审评、发布和终止程序、应对2009年H1N1流感取得的成功经验以及EUA实施过程中遇到的挑战进行分析。同时与日本应对2009年H1N1大流行时对ArepanrixTMA/H1N1流感疫苗和Novartis H1N1流感疫苗的紧急授权进行比较分析。
基金Supported by Major Projects of the Chinese PLA “Thirteenth Five-Year Plan”Logistics Research Subject,No.AKJ15J003 and No.AKJ15J001Incubation Project of Military Medical Science and Technology Youth Cultivation Program,No.17QNP023
文摘BACKGROUND Colorectal cancer(CRC)could seriously threaten the physical and mental health of pilots.Shall they end their flying after treatment of CRC?With this study,we investigated the possibility of a gradual medical waiver for such pilots to fly aircrafts again after treatment of CRC.CASE SUMMARY We analyzed the medical waiver and clinical data of 3 pilots with CRC,who had accepted the treatment at the Department of General Surgery,Air Force Medical Center(formerly,Air Force General Hospital)between 2013 and 2018.All 3 cases underwent a series of comprehensive treatment courses,including radical resection of CRC,sequential radiotherapy,and chemotherapy.The follow-up results were satisfactory.After passing through the high-risk period of recurrence and metastasis of CRC,they all were given a medical waiver for flying again.Medical observation showed that their flying operations were safe.CONCLUSION The CRC treatment shall follow the guidelines for diagnosis and treatment and should simultaneously protect the combating capabilities of pilots as much as possible.It is safe for pilots with CRC,who are continuously monitored under medical observation after passing through the high-risk period of recurrence and metastasis,to undertake military flight missions again.
