Drugs

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. Additional guidance documents, when available in draft or final form, will be added to these pages.

Submission Addresses for Electronic Documents

Send all electronic submissions (except ANDAs) to:
Food and Drug Administration
Center for Drug Evaluation and Research
Central Document Room
5901-B Ammendale Road
Beltsville, MD 20705-1266

Send ANDA submissions to:
Office of Generic Drugs
Generic Drugs (HFD-600)
Center for Drug Evaluation and Research
Food and Drug Administration
Metro Park North VII
7620 Standish Place
Rockville, MD 20855

General Considerations

CDER and the Center for Biologics Evaluation and Research (CBER) have co-published a guidance document called Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (PDF - 288KB). This document provides general information about the electronic submissions process.
For more information on guidance documents, please contact esub@fda.hhs.gov.

Abbreviated New Drug Applications (ANDAs)

Please refer to:

Drug Master Files (DMFs)

DMFs should be submitted in eCTD or paper format only. Please refer to:

Guidance for Industry: Drug Master Files (DMFs)
For general DMF questions, please contact dmfquestion@cder.fda.gov.
For more information on electronic submissions for DMF, please contact esub@fda.hhs.gov.

Investigational New Drug Applications (INDs)

CDER accepts INDs submitted in eCTD or paper format. Please refer to:

Providing Regulatory Submissions in Electronic Format - Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (PDF - 288KB)
On March 26, 2002, FDA published the final guidance on the submission of INDs in electronic format to the Center for Biologics Evaluation and Research (CBER) (PDF - 80KB). Once the IND submission to CBER is posted on public docket 92S-0251, we will be capable of accepting INDs submitted to CBER in electronic format without paper copies. At this time, we are not extending this to INDs submitted to CDER.

New Drug Applications (NDAs)

Please refer to:

Providing Regulatory Submissions in Electronic Format - Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (PDF - 288KB)

FDA Electronic Submissions Gateway (ESG)

FDA Electronic Submissions Gateway:
CDER's preferred method of submission is via the FDA Electronic Submissions Gateway (ESG). For more information on the FDA ESG, see the Electronic Submissions Gateway page.
Fillable Forms and Automated Processing:
For automated processing of your submissions, submit an FDA fillable form with each submission. Using a fillable form with or without an additional signed scanned form (and no errors present in the submission) means the submission can be in the hands of the FDA Project Manager and Reviewers in as little as 10 minutes after it is successfully received by FDA via the ESG. This is applicable to both eCTD and non-eCTD submissions.
Important Note:
If, for some reason, you are unable to submit a fully completed fillable form, with an electronic signature, you could submit the completed fillable form (not scanned) without the signature and then provide a second 356h form that uses another method of signature (i.e., a scanned signature). When including a second complete 356h form, do not include "356h" anywhere in the file name. We recommend that you use a filename like "signed-form.pdf" or something similar, while the fillable form would be named "356h.pdf." This will allow our automated systems to correctly find your fillable form, read it, and process your submission appropriately.

Electronic Document Room (EDR) / Physical Media

Physical Media:
When submitting via physical media, it is recommended that you submit a paper copy of the cover letter (with contact information) and FDA form in case the physical media proves to be unreadable. For more information, please refer to: Specification for Transmitting Electronic Submissions Using eCTD Specifications.
All submissions on physical media should be sent to the EDR via the addresses at the top of this page.
Submissions on physical media are loaded and validated through the EDR.
If you are submitting through the ESG, it is not necessary to also send physical media to the EDR.
For more information on allowable file types or other questions dealing with electronic submissions, please contact esub@fda.hhs.gov.

Secure Electronic Mail

Secure email 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 SecureEmail@fda.hhs.gov.

Technical Assistance

For eCTD questions and more general information regarding the preparation of submissions in electronic format, please contact the CDER Electronic Submission (CDER ESUB) Support Team at esub@fda.hhs.gov and questions regarding datasets should be forwarded to the CDER eDATA team at cder-edata@fda.hhs.gov.