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PDUFA IV Electronic Applications and Submissions Accomplishments

FY 2008 PDUFA Performance Report Table of Contents

The electronic applications and submissions initiatives FDA committed to achieve under PDUFA IV were designed to improve the overall application review process. Please see Appendix A for specific details about the initiatives.

Electronic Applications and Submissions Initiative FY 2008 Accomplishments
Develop and periodically update an IT plan, covering a rolling 5-year planning horizon. The final PDUFA IV IT Plan was published in June 2008.
Develop, implement, and maintain new information systems consistently across all organizational divisions participating in the process for the review of human drug applications. The Bioinformatics Board coordinates and oversees all activities related to business automation planning, acquisition, and implementation decisions throughout FDA, under a strategic framework for automation established by the Commissioner and implemented by the FDA Management Council. The Bioinformatics Board has approved the following projects to support the review of human drug applications across the FDA Centers: Common Electronic Document Room, Information Computing Technologies for the 21st Century, the Janus Initiative and Regulated Product Submission.
Update technical specifications and IT-related guidance documents as necessary. ● FDA published the final guidance: Providing Regulatory Submissions in Electronic Format--Human Pharmaceutical Applications and Related Submissions Using the eCTD Specifications.
● FDA published: Providing Regulatory Submissions in Electronic Format –Drug Establishment Registration and Drug Listing.
● FDA published: Indexing Structured Product Labeling.
● FDA published the draft guidance: Providing Regulatory Submissions in Electronic format – Postmarketing Individual Case Safety Reports.
● FDA published the technical specification: Specifications for eCTD Validation Criteria.
Extend the capability of the secure electronic single point of entry to include two-way transmission of regulatory correspondence. ● Regulated Product Submission (RPS) is a data exchange standard to facilitate the processing and review of regulated product information. (RPS) Release 2 will support two-way communication and was approved as a Health Level 7 project. FDA finalized the concept proposal in September 2008.
Establish an automated standards-based regulatory submission and review environment for INDs, NDAs, and BLAs, and their supplements. ● The FDA Common Electronic Document Room project will establish a common, agency-wide, standards based electronic document room. The Bioinformatics Board approved the Concept proposal in February 2008, Boundary document in February 2008 and Project Charter in November 2007. Contracts were awarded to support business modeling and provide technical services for this project in September 2008. 
Establish a system for electronic exchange and management of human drug labeling information in a modular manner that is based on FDA standards and that enables revision tracking. ● FDA participated in the development of the Health Level 7 data exchange standard, Structured Product Labeling, as a component to support automated, standards-based exchange of human drug labeling information.
● FDA tested a prototype of a collaboration portal system that would support the Health Level 7 Structured Product Labeling standard. FDA is currently evaluating the next steps for the program. 
Establish standards-based information systems to support how FDA obtains and analyzes post-market drug safety data and manages emerging drug safety information.

● In May 2008, FDA launched the Sentinel Initiative which will enable FDA to query multiple, existing data sources for information about medical products. FDA hosted several public information sharing meetings in FY 2008 with external stakeholders for the Sentinel Initiative.
● In March 2008, FDA awarded a contract to support the MedWatch Plus initiative which will develop a "portal through which adverse event, consumer complaint, and product problem reports are received and processed to make the information available to adverse event analysis systems." Based on the HL7 ICSR standard, this portal is intended to include a "Rational Questionnaire" that consumers could use to complete an on-line form that has imbedded logic to support the distribution of adverse event reports to appropriate government agencies. FDA completed the following activities for the MedWatch Plus Initiative:        

 ● Conducted demonstrations of commercial products
 ● Completed the Paper Reduction Act 60 Day Notice estimating the reporting burden for MedWatch Plus and the Rational Questionnaire  

Next page: Appendix A: PDUFA IV Performance Goals, FY 2008 FY 2012

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