Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications

FDA has identified certain submission types that warrant an exemption (Type III drug master files (DMFs)) or a long-term waiver (certain positron emission tomography (PET) drug products and certain Type II DMFs supporting PET drugs or noncommercial submissions or applications) from the requirement to submit to the Agency in electronic common technical document (eCTD) format. In addition, this guidance outlines certain circumstances where FDA may determine that a short-term waiver from eCTD submission requirements could be granted. This guidance finalizes the revised draft guidance of the same title issued in July 2019 and replaces the final guidance issued in January 2019 (Revision 6).