A reminder that Electronic Common Technical Document (eCTD) deadlines are approaching. All submissions to the FDA including NDA, ANDA, BLA and DMFs are required to be submitted in eCTD format beginning on May 5, 2017. IND submissions are required to be submitted in eCTD format beginning on May 5, 2018. FDA informs that submissions that do not meet the specifications in the eCTD guidance will not be filed or received. Paper will no longer be accepted after the dates noted.
Pearl Pathways has an experienced team to help with your regulatory submission authoring, publishing, and eCTD filings. Contact us for a value added partner to assure no interruption in your regulatory filings.