FDA electronic submission

YOU ARf ENTERING Tl- FDA ELECTRONIC SUBMISSIONS GATEWAY TEST ENVIROWENT. THIS ENVIRONMENT IS TO BE USEO FOR TEST SUBMISSIONS OU.Y. 

Case Report Tabulation Data Definition Specification (Define.xml). Define.xml is the upcoming replacement for the data definition file (define.pdf) sent to the FDA with electronic submissions. Define.xml is based on the CDISC ODM model and is intended to provide a machine-readable version of define.pdf. Because define.xml is machine readable, the metadata about the submission data sets can be easily read by computer applications. This allows the FDA to work more easily with the data submitted to it. 

This guidance document describes how a New Drug Application (NDA) may be sent electronically to the FDA. The guidance defines how the files in the electronic submission should be structured for FDA review. 

The Electronic Common Technical Document (eCTD) is the vision for future electronic submissions to the FDA. This specification was developed by the International Conference on Harmonization (ICH) as an open-standards solution for electronic submissions to worldwide regulatory authorities. The FDA has adopted the eCTD as the future replacement for its other e-submission guidance, although for now the older guidance is still in effect. Note that the eCTD still depends largely on submitting text documents as PDF files and submitting data sets as SAS XPORT transport format files. 

The continuous advancements made in computer technology programs to expedite information increase the access of information to its perspective audience. This enables the information to become more accessible and attainable. The submission coordinators of the FDA work with drug marketers on technical issues relating to labeling submissions. The SPL and Electronic Submission Guideline documents are part of these advancements. 

Electronic Submission Guidance documents can be found at http //www.fda.gov/cder/guidance... 

There are some common administrative elements for all applications. For example, a cover letter should address the purpose of the submission and make reference to any relevant previous submissions or previous agreements with FDA. To the extent possible, a summary of the information provided in the submission should be included. Cover letters should also include, if applicable, the assigned application or serial number, user fee information, contact persons, a description of the sections being submitted on paper and being submitted electronically, and an antivirus statement for electronic submissions. 

The quality of a submission depends not only on the content of the submission but the tools provided to facilitate the review process. Now more than ever, FDA reviewers are receptive to electronic review aids and the use of electronic files. Simple and relatively inexpensive approaches are available. Important issues to consider during planning include the need for electronic review aids. These are electronic tools requested by the reviewer outside the electronic submission policy. Examples of these include book-marked, searchable versions of the integrated summaries and final clinical study reports for the core studies on CD-ROM or Microsoft Word versions of summaries that reviewers can cut and paste for their reviews. Since the preparation of the review summary can often be the longest part of the review, providing these tools can be useful in significantly reducing the total review time. 

Both CDER and CBER have indicated that they will stop accepting paper submissions in the near future, although the actual date for these mandates is not clearly defined. Under PDUFAII commitments, FDA agreed to develop a paperless electronic submission program for all applications by 2002. This means that companies planning submissions should develop standards and procedures to ensure that the electronic submission requirements can be met. 

Several software development companies have developed software to meet FDA s extensive electronic submission requirements. As a quick solution to the electronic submission requirements, some firms have purchased these software programs. Other companies have elected to develop an in-house solution to this challenge. Avery important factor in the development of electronic submissions systems is the development of company-specific user requirements that describe the current procedures for handling documents at the company and the needs for any electronic system. These needs... 

Examine electronic submission options. Most FDA submissions can be made manually (paper) or electronically. Obviously, the electronic submission process is more efficient, particularly when delivering large documents (INDs routinely run over 5,000 pages NDAs may be even larger), ffowever, there are some additional considerations. 

Electronic submission standards are evolving and may not be clearly established for all FDA groups and divisions. The common electronic submission gateway (ESG, see Chapter 1 FDA Documents) is sometimes problematic. 

FDA ESG This document provides an overview of the process of electronic submissions and provides registration and confirmation processes as well as links to electronic submission requirements of the Center for Biologies Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), the Center for Veterinary Medicine (CVM), the Adverse Events Reporting System (AERS), and the Center for Devices and Radiological Health (CDRH). 

The business of the FDA is extremely information intensive. In recognition of this fact and of the potential benefits offered by information technology for assisting with the management of information, the FDA has undertaken a number of projects supporting the electronic submission of text and data from the industries it regulates. 

The objective of this User Guide is to provide industry participants with information and guidance on how to prepare and send documents through the FDA ESG. A list of submissions that the FDA ESG will accept is given in Table 1.2. This document provides a high level description of the electronic submission process via the FDA ESG. 

Understand Submission Guidelines. Each FDA Center has specific guidelines that must be followed for successful submission. Table 1.1 contains links to Center-specific preparation guidelines and contacts. Table 1.2 lists electronic submissions supported by the FDA ESG. Important information on the use of digital/electronic signatures on FDA forms can be found in Appendix C, Digital Signatures. 

The steps for the electronic submission process for FDA ESG Web Interface users are provided in the following sections. 

The ERSR Web page (http //www.fda.gov/cder/regulatory/ersr) provides information about the electronic submission of regulatory information to the Center and its review by CDER staff. Additional guidance documents, when available in draft or final form, will be added to the Web page. 

For more information on electronic submissions for DMF, please contact CDER at esub fda.hhs.gov. General DMF questions may be sent to dmfquestion cder.fda.gov. 

AERS. A pilot program for electronic submission of individual case safety reports is now being conducted with pharmaceutical manufacturers with approved products. The format follows the International Conference on Harmonization (ICH) standards. For more information on the ICH, please contact Timothy Mahoney at mahoneyt cder.fda.gov. 

Technical Assistance. For more general information regarding the preparation of submissions in electronic format, please contact the Electronic Submissions Coordinator at esub fda.hhs.gov. 

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