FDA Extends Compliance Date for Submitting DMFs in eCTD format

The FDA announced on Friday, April 7th, that it is extending by one year the deadline for submitting DMFs in eCTD format. See the revised “eCTD guidance document”:https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM333969.pdf and more information on “DMF submssions here”:https://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/DrugMasterFilesDMFs/ucm2007046.htm .

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