FDA Extends eCTD Compliance Date for DMFs From May 2017 to May 2018

Less than a month before eCTD submissions of drug and biologic master files were to become mandatory, FDA announced that it had postponed the requirement: “NOTE: On April 7, 2017 the FDA announced that it is extending the compliance date for submitting DMFs in eCTD format to May 5, 2018. These webinars were created prior to April 7, 2017 and have the incorrect DMF compliance date”. Click here for a useful FDA eCTD DMF Tip Sheet, or here for help.