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April 20, 2017

Type III DMFs Deadline Extended to May 5, 2018

Starting May 5, 2018, new DMFs, new BPFs, and any submissions to existing DMFs and BPFs (e.g., amendments, annual reports, LOAs) must be submitted using the eCTD 3.2.2 standard. All submissions must be submitted electronically even if the remainder of the master file is on paper. DMF submissions that are not submitted in eCTD format after May 5, 2018, will not be filed or received. The eCTD standard will be updated in the future. The current requirements and supported versions can be found in the FDA Data Standards Catalog at www.fda.gov/eStudyResources.

Montesino can help you write, organize and submit your company’s DMFs in compliance with the new FDA regulations. Please see how we can help you here.







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