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Electronic Regulatory Submissions

Submission of Electronic Documents 

 

General Considerations

  • CDER and the Center for Biologics Evaluation and Research (CBER), has co-published a guidance document called Guidance for Industry: Providing Regulatory Submissions in Electronic Format - General Considerations (PDF - 54 KB). 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).
  • For more information on ERSR guidance documents, please contact Randy Levin at randy.levin@fda.hhs.gov.

 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," (PDF - 150KB) 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.

 Drug Master File (DMF)

 

 Investigational New Drug Applications (INDs)

  • On March 26, 2002, FDA published final guidance on the submission of INDs in electronic format to the Center for Biologics Evaluation and Research (CBER). 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.

    The electronic IND guidance leverages the current BLA/NDA guidances and the experience set from CBER's eIND pilot program. This guidance features PDF tables of contents, roadmap files, and a folder structure that enables the reviewer to easily access and review documents. We expect the experience of receiving the IND applications and amendments with or without media, featuring an electronic signature, as well as the review of these electronic INDs submissions to help the FDA further other electronic submission initiatives.

    In the future, we plan on upgrading the electronic IND filing and review process to include the use of XML-based technology. We are currently working toward accepting the electronic common technical document using XML for marketing applications and will build on this to accept XML-based electronic INDs. Once this is completed, we will then issue draft guidance that incorporates the XML-based technology for all INDs including those submitted to CDER. We hope to have XML specifications for electronic INDs available in 2003.

 Launch Material and Other Submissions to the Division of Drug Marketing, Advertising, and Communications (DDMAC)

 New Drug Applications (NDAs)

Postmarketing Adverse Events Reporting

Voluntary Electronic Submissions

  • Postmarketing Expedited and Periodic ICSRs [PDF] Memoranda to Docket 92S-0251 that allows for voluntary electronic submission of all postmarketing individual case safety reports, whether expedited or periodic, in electronic format in place of paper.
  • Descriptive Information of Periodic Reports [PDF] Memorandum to Docket 92S-0251 that allows for voluntary electronic submission of the descriptive information of postmarketing periodic adverse experience reports in electronic format in place of paper.

Guidances

Specifications

Submit comments and queries on these specifications to the AERS Electronic Submission Coordinator at aersesub@fda.hhs.gov.

Related Information 

Related Web Sites

 

    
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