ࡱ> UWT` 7bjbjss .*7tttttttPPPPdT___SSSSSSS$Uh]X(StC__CCSttSCvttSCSRH4tt\7x ;P"5SS0T5bZ Z<\7\7"Zt~7_"___SS___TCCCClltttttt Written Notice of Participation by a group of Medical Writers who belong to the Drug Information Association (DIA) Medical Writing Special Interest Area Community (SIAC) Written Statement for Discussion Topics to be Addressed In the FDA Public Hearing: Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management Docket No. 2006N-0464 Date to be Held: December 18, 2006 Comments, Grouped by Questions in the Docket: The electronic submission of regulatory information is clearly a beneficial goal as a means ultimately to decrease submission time, facilitate easy conversion for submission to other regions of the world, and provide a more easily accessible base of knowledge that can be searched and used to make safety assessments. We enthusiastically support this goal, and would like to participate in this effort by making these comments: Some product areas are not ready to accept information entirely electronically; some submission types are more problematic presently, for example, promotional material. DDMAC has not established a document base or procedures to accept and manage electronic submissions. Some types of hard-copy legacy documents, such as engineering drawings, may be difficult to convert to an electronic format. Thus, an implementation plan needs to be in place before FDA sets target dates. The plan should consider which product types and submission types are lagging behind in guidance development and provide recommendations (hybrid options) and some exceptions. The present eCTD guidance is limited to the applicable products and types of submissions that can reasonably be included. But the Study Tagging Files based on ICH E3 for clinical data are not easily applicable to nonclinical reports, or to medical devices. There is a need for FDA to provide joint guidance and procedures, for all centers, on the submission of electronic information. It is important to develop electronic exchange standards through an industry and agency collaboration facilitated by Standards Development Organizations like the HL7 RCRIM and CDISC. When both industry and agency are involved in the creation of the standard, all parties can evaluate their infrastructure and help alter the standard to be more cost effective early in the process. Broad participation and a disciplined approach have positive effects and produce a more robust standard in less time. Full support and participation should be provided to this process. The requirement within21CFR11 to validate closed systems does not explicitly state,or elude to, what a validated system is, nor does it take into consideration the time and resources required to validate such systems. Further, industry vendors who provide software solutions (e.g., eCTD Publishing systems)are freely able topush major updates of their software out to their clientsand discontinue supporting previous versions, thus, forcing their clients to upgrade their systems. This causes a tremendous burden on time and resources that can be dedicated to other areas ofdrug development.With an FDA mandate to produceeCTD-based submissions by January 1, 2008, can serious consideration begiven to the following: More explicitly define what a validated system is and what the FDA's expectations are of these systems. Provide flexibility to industry sponsors who choose to produce eCTD-based submissions in-house byproviding less restrictive provisions for validating system enhancements versus FDA required functionality. Small companies and biotech firms do not clearly understand the simpler options are for producing 21 CFR Part 11 compliant electronic submissions. Perhaps more information on these tools and options would be useful in removing some roadblocks. Using the Firebird project options and the Gateway would be a benefit to smaller companies; dissemination of the information on this can be better, especially to those groups who do not have the travel budget to attend industry meetings nor the staff to maintain web monitoring for new information. Clarification of existing guidances by Webinars and other cost-effective communication tools would be valuable in moving forward toward an electronic environment. There is no clear guidance regarding the eCTD format for INDs. Currently the format needs to be negotiated with the appropriate division at the agency. This lack of uniformity confounds sponsors with several INDs to file with different divisions. Will there be a guidance issued regarding uniform IND eCTD format? If so, when? The cost associated with development of infrastructure within the company/institution can be prohibitive, particularly for small companies, which do not have the internal expertise necessary for a mandatory transition to all-e submissions. Operational aspects of development require collaborative expertise in IT, project management, and regulatory, above and beyond the skills and expertise required to make a paper or hybrid submission. There are a few, relatively expensive choices entities available to provide such services or tools in support of this effort. Even off-the-shelf types of packages require some level of customization and training. At least 2 more years (2010) should be required before making e-submission mandatory, then a phased-in approach would be recommended. A major impediment to all electronic submissions is the integration of XML technology and tools. This is particularly problematic for small companies, which lack resources for software, staff, and training. 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