FDA推迟DMF的eCTD强制实施日期至2018年5月5日

Notice 4/7/2017
FDA Extends Compliance Date for Submitting DMFs in eCTD format

The FDA extended the compliance date for submitting DMF’s in eCTD format to May 5, 2018. See the FDA guidance document for additional information on the compliance date and FDA’s Drug Master File page for additional information on DMFs.

FDA于4月7日发布通知，将推迟eCTD格式DMF申报的强制实施日期至2018年5月5日。

通知网页如下：

https://www.fda.gov/drugs/developmentapprovalprocess/formssubmissionrequirements/electronicsubmissions/ucm153574.htm#Past_Notices

通知截屏如下

                               
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更新后指南链接如下
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM333969.pdf