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U.S. Department of Health and Human Services

Drugs

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Electronic Regulatory Submission and Review (ERSR)

Welcome to the Center for Drug Evaluation and Research's Electronic Regulatory Submissions and Review (ERSR) web page. 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 this page.

NOTICE: Click here for important instructions regarding electronic submissions, effective January 1, 2008.

Electronic Regulatory Submissions

Submission of Electronic Documents (6/7/2004)

  • Send all electronic submissions (except ANDAs) to:
    5901-B Ammendale Road
    Beltsville, MD 20705
  • Send ANDA submissions to:
    7500 Standish Place, E-150
    Rockville, MD 20855

Electronic Review

Helpful Links

Electronic Regulatory Submissions

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 - General Considerations (PDF - 288KB). This document provides general information about the electronic submissions process.
  • Note: In the general considerations guidance, we recommend the following: Digital Tape - Digital Equipment Corp. DLT 20/40 and 10/20 GB format using OPENVMS with VMS backup or NT server 4.0 with NT backup or backup exec."

    Since the release of this guidance, there have been some changes in CDER. First, we are currently not able to accept tapes using OPENVMS with VMS backup. Second, we are able to use 35/70 DLT tapes. We are not, however, able to handle 40/80 DLT tapes. We are working on an update to this guidance and plan to add this information accordingly. (Posted 3/1/2001)

    Since the above posting on March 1, 2001, CDER is now able to handle 40/80 DLT tapes though we prefer 35/70. CDER cannot process DLT tapes that have been prepared using the backup applet included with the Windows 2000 operating system. It is recommended that systems running Windows 2000 use backup exec to produce the DLT transport tape for CDER. (Posted 9/28/01).

 Abbreviated New Drug Applications (ANDAs)

  • Information on electronic datasets that accompany an ANDA submission:

    You may now submit ANDAs in electronic format in place of paper. We have placed the ANDA on public docket 92S-0251 as a submission acceptable in electronic format as allowed under 21 CFR Part 11. It should be noted that Part 11 requires that datasets provided in electronic format and used in the review process meet the requirements for archiving, i.e., protection of those records to enable their accurate and ready retrieval throughout the records retention period.

    Electronic datasets, including those accompanying a paper submission cannot be considered as official and used to support the application if they are submitted in a file format that is not archivable. As FDA and industry progress in meeting the goals of use of electronic submissions, compliance with electronic submission regulations will be expected. Typically, electronic datasets accompany an ANDA application to support the review of bioequivalence studies. With the implementation of the guidance for industry Providing Regulatory Submissions in Electronic Format – ANDAs (June 2002), the submission of these dataset records for use in the review should be in archivable format. At this time, the archival dataset format is SAS Transport. (Posted 7/15/2002)
  • Guidance for Industry: Providing Regulatory Submissions in Electronic Format - General Considerations (PDF - 288KB)

 Annual Reports for New Drug Applications (NDAs)

 Carcinogenicity Data

  • An example of a SAS transport file for carcinogenicity data set is available. This is a self-extracting ZIP file that will be loaded to your C drive. If you download this file, the path to the example is: C:\WINDOWS\TEMP\example\N123456\pharmtox\datasets\101.  
    For more information on carcinogenicity data, please contact Karl Lin at karl.lin@fda.hhs.gov.

 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 "Link to 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.

 Drug Master File (DMF)

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 Investigational New Drug Applications (INDs)

 

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