Wednesday, The FDA Issued A Complete Response Letter Covering Novo Nordisk's Biologics License Application For Once-weekly Basal Insulin Icodec For Diabetes Mellitus
Wednesday, The FDA Issued A Complete Response Letter Covering Novo Nordisk's Biologics License Application For Once-weekly Basal Insulin Icodec For Diabetes Mellitus
週三，美國食品藥品監督管理局針對諾和諾德公司針對糖尿病患者的每週一次基礎胰島素icodec的生物製品許可申請發出了一封完整回覆信。
In the letter, the FDA has requests related to the manufacturing process and the type 1 diabetes indication before the review of the application can be completed. Novo Nordisk is evaluating the content of the CRL and will work closely with the FDA to fulfil the requests. Novo Nordisk does not expect to be able to fulfil the requests during 2024.
在信中，在完成對申請的審查之前，美國食品和藥物管理局提出了與製造過程和1型糖尿病適應症有關的要求。諾和諾德正在評估CRL的內容，並將與美國食品藥品管理局密切合作以滿足這些要求。諾和諾德預計無法在2024年滿足這些請求。
譯文內容由第三人軟體翻譯。
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