With the May, 2018 FDA mandate quickly approaching, conversion of paper IND’s, NDA’s, and DMF’s to eCTD format must happen soon. Here are some tips for a successful eCTD conversion.
- It is important to note that once an eCTD submission has been made to an application all subsequent submissions to that application must also be in eCTD format. Typically, the first submission sent to the application as an eCTD will contain the appropriate form (1571 or 356h) and cover letter indicating that all future submissions to the application will be done in eCTD format.
- After the first eCTD sequence is sent, sponsors should submit new information only to the IND. It is not necessary to resubmit information that has been previously submitted to the application in paper or non-eCTD format.
- When a sponsor company references information that was previously submitted in non-eCTD format, the sponsor should provide enough information so that the reviewer can locate the referenced information. A common practice for cross referencing previously submitted material includes providing the application or master file number, serial number, date of submission (e.g. cover letter date), the document name, and volume/page number within the referenced document that contains the supportive or relevant information referenced in the new document. A document detailing previously submitted information that is referenced by the current application can be submitted in Module 1, Section 1.4.4 Cross Reference to Other Applications of the eCTD.
Contact Synchrogenix today at firstname.lastname@example.org to help your company achieve submission success simply, quickly, and cost-effectively.