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.

Transcript (PDF)

How to Send Your eCTD Submissions to the FDA

Directions for submitting your eCTD submissions can be found in the Specification for Transmitting Electronic Submissions Using eCTD Specifications.

FDA’s preferred method of submission is via the FDA Electronic Submissions Gateway (ESG).  For more information, see the Electronic Submissions Gateway web page.

For automated processing of your submissions, use the ESG and submit an FDA fillable form with each submission.  Including a correctly completed FDA fillable form with a valid formatted submission allows FDA staff quicker access to the submission after it is successfully received by the Center via the ESG.

Instructions and addresses for submitting on physical media, when this becomes necessary, are also included in the specification.

Secure Electronic Mail

Secure e-mail between CDER and industry is useful for informal communications when confidential information may be included in the message (for example, trade secrets or patient information).  Secure e-mail should not be used for formal regulatory submissions (for example, NDAs, INDs, amendments and supplements).

For more information on establishing a Secure Electronic Mail link with CDER, contact [email protected].