Electronic Regulatory Submission

and Review
This page provides information about the electronic submission of regulatory
information to the Center and the review of it by CDER staff. The Electronic
Common Technical Document (eCTD) is the standard, accepted electronic format for
the following submission types:

 New Drug Application (NDA)

 Abbreviated New Drug Application (ANDA)
 Investigational New Drug Application (IND)
 Biologics License Application (BLA)
 Master files: Drug Master File (DMF) and Biologics Master File (BMF)
 Emergency Use Authorization (EUA)

Please visit the Electronic Common Technical Document (eCTD) web page to access
a wide variety of resources and support regarding eCTD submissions.

Instruction for Guidance Compliant Test Submission:

(Use WebTrader test account. See Setting up a Web Trader Account Checklist for
details)

CDER requests the Guidance Compliant Test Submission in order to validate the
format of your submission, your understanding of entire submission process, and to
make sure FDA systems can receive and load your submissions.

 NDA, BLA, ANDA, DMF, and Commercial IND guidance compliant test
submissions must be in eCTD format: 
o Select “CDER” as the Center 
o Select “ECTD” as Submission Type 
o Use any 6-digit number as the test application number 
o Select an eCTD sequence folder. Do not submit a single file as this will
not pass validation. Do not include .exe, zip files, RAR files or other
archives as this will not pass validation. 
o The test submission must contain at least Module 1, FDA Form (356h
for NDA/BLA/ANDA or 1571 for IND, no form for DMF), cover letter,
and all XML components *
 Non-commercial/Research IND guidance compliant test submissions must be
either eCTD or a folder containing the non-eCTD file(s) 
o For eCTD test submissions, follow instructions above 
o For non-eCTD Submissions (only for Non-commercial IND
submissions), select “CDER” as the Center and select “EIND” as
Submission Type 
o Select a folder with eIND documents. Do not submit a single file as this
will not pass validation. Do not include .exe, zip files, RAR files or other
archives as this will not pass validation.

* An eCTD publishing tool is recommended to automatically create the eCTD

sequence folder and file structure. FDA does not recommend specific tool
vendors, however, they can be located via internet search.

For information on eCTD format, please see www.fda.gov/ectd

Questions and general information regarding the preparation of submissions

in electronic format may be directed to CDER at esub@fda.hhs.gov or CBER
at esubprep@cber.fda.gov. Questions regarding submission of datasets to
CDER may be sent to edata@fda.hhs.gov.
 

 IND Forms and Instructions

New Drug Application (NDA)