Announcement: See GlobalSubmit’s web site for a brand new presentations page linking to recent agency presentations!
GlobalSubmit recently attended two informative DIA conferences:
During these conferences, industry received updates from a number of regulators, including the FDA, Health Canada, the European Medicines Agency, the MEB, AGES PharmMed, and SwissMedic. In my next series of blog postings, I’ll be passing on interesting news from the regulators. Since there’s quite a bit of material, I’ll cover it in three postings: US, Canada, and Europe.
The FDA’s presentations focused on three major areas:
Status and metrics for FDA initiatives
Gary Gensinger provided updates in both San Diego and Vienna. Some of the more significant metrics included:
Gary spoke about the importance of the emerging RPS standard. He emphasized that RPS is critical to FDA’s meeting their PDUFA IV commitments – as well as supporting their goal of to conducting all their business electronically. Gary referenced a Draft Standard for Trial Use (DSTU) date of January 2010, and a target acceptance date for RPS Submissions for drugs and biologics of the 4th quarter of 2011.
Gary also provided an update on the DARRTS initiative. DARRTS is “A flexible, integrated, fully electronic workflow tracking and information management system to receive, log, track, assign, process, and manage official submissions with internal and external stakeholders. The system maintains the official submission records and will manage and track all communications and documentation concerning submission.” Release 3 of DARRTS was implemented successfully in July 2009, resulting in the retirement of 17 legacy systems. Phase 4 (CDER and CBER BLAs) is being planned.
Lilliam Rosario described a major FDA challenge: The FDA receives massive amounts of clinical research data in extremely disparate formats, using a variety of proprietary standards. This makes it extremely difficult, if not impossible, to do cross-study and application reviews.
FDA has been working towards a standardized approach to capture, receive, and analyze study data. Standardization of study data is vital to integrate pre-marketing study data and post-marketing safety data to improve public health and patient safety. Central to this vision is the creation of an enterprise data infrastructure within FDA to improve the management of all structured scientific data (Janus).
Data standards to support this vision are needed in three broad categories: Exchange standards, analysis standards, and terminology standards. FDA is moving towards XML exchange standards based on the HL7 Reference Information Model to submit study data to the FDA. FDA is also currently working on a proposed rule that would require the electronic submission of study data to the FDA. Study data content for creation of SDTM views will be sent to FDA as an XML files modeled using the HL7 RIM.
Study Tagging Files
Virginia Ventura of the Office of Business Process Support spoke on “Study Tagging Files: Their Vital Role In Submissions To The FDA.”
Virginia described some of the most common problems she sees with STFs:
She clarified that an STF is needed any time you are including documents in Modules 4 or 5, except 5.2 Tabular Listings, and 4.3 or 5.4 Literature references.
A case study provided by Virginia should give sponsors pause.
She continued by providing descriptions of additional problems and their correction strategies:
And wrapped up with some sound advice if you run into problems:
Next time… Health Canada news.
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