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 .
April 07, 2017