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:
- Select “CDER” as the Center
- Select “ECTD” as Submission Type
- Use any 6-digit number as the test application number
- 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.
- 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)
- For eCTD test submissions, follow instructions above
- For non-eCTD Submissions (only for Non-commercial IND submissions), select “CDER” as the Center and select “EIND” as Submission Type
- 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 [email protected] or CBER at [email protected]. Questions regarding submission of datasets to CDER may be sent to [email protected].
Transcript
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].
Providing Digital Electrocardiogram (ECG) Data
Why:
FDA is interested in having access to ECG waveform data collected during the course of "definitive" studies on drug effects on ventricular repolarization and annotated for interval measurements. The basis for this interest is described in detail in the concept paper, "The Clinical Evaluation of QT Interval Prolongation and Proarrhythmic Potential for Non-antiarrhythmic Drugs," jointly authored by the U.S. and Canadian regulatory authorities and discussed at a joint FDA/DIA meeting in January 2003.How:
In 2004, FDA announced its intent to accept annotated ECG waveform data in electronic format (XML) following the Health Level Seven (HL7) Annotated ECG Waveform Data Standard (aECG) accredited by the American National Standards Institute. You can find more detailed information on the aECG message standard and supporting materials by visiting the HL7 Version 3 ECG page and following the "ECG Annotation Message Review Material." To facilitate access to the aECG data, FDA has entered into a Cooperative Research and Development Agreement (CRADA) with Mortara Instruments to develop and implement a digital data warehouse to collect, store, and archive aECG data from controlled clinical trials. FDA reviewers have access to this data warehouse to support their assessment of the risk of new drugs.You can upload data to the warehouse for FDA access at the Mortara ECG Warehouse. For questions, contact the project manager in the appropriate review division.