News | November 1, 2007

FDA Withdraws Three Electronic Submission Guidances In Favor Of eCTD

The Drug Information Association (DIA) will host its 6th Annual Electronic Submissions Conference: The Future Is Now (November 14-16, 2007; San Diego, CA) to discuss the impact of the Center for Drug Evaluation and Research's (CDER) withdraw of three electronic submission guidances in favor of a new guidance promoting the use of the eCTD format. This new guidance becomes effecrive on December 31, 2007.

"This is another important step in the Center's avowed policy of advancing the eCTD format," says Gary M. Gensinger, Program Co-chair and Director, Regulatory Review Support Staff, CDER, FDA. "The previous guidances are no longer consistent with more recent guidances and no longer reflect the agency's preferred format for receiving electronic submissions."

While CDER recommends the eCTD format, many sponsors are not prepared to support the format with current processes and technologies and many more are not comfortable with their organizations' understanding of the eCTD format. In response to sponsors' needs, this conference will:

  • Describe the impact of CDER's withdrawal of the eNDA guidances;
  • Identify challenges and benefits of transitioning from paper to eCTD;
  • Explain the various methods of electronic transmissions to FDA; and
  • Provide best practices for creating guidance-compliant INDs and NDAs in eCTD format.

Parallel tracks for intermediate and advanced-level attendees will include topics on:

  • Preparing the Organization for Electronic Submissions
  • Leveraging Content Management and Emerging Standards
  • Making the Change: The Workflow Impact of the Transition to eCTD
  • eCTD — INDs
  • Preparing for Your FDA eCTD Pilot and eCTD Submission
  • Multiregional Marketing Applications
  • Tool Selection: From Low Budget to Deep Pockets
  • Beyond the eCTD Format: Managing the Lifecycle and eLabeling

For more information, contact Jessica Kusma at +1-215-442-6182 or Jessica.Kusma@diahome.org . Media interested in attending the event or arranging for pre- or post-event interviews should contact Joe Krasowski at Joe.Krasowski@diahome.org or 215-293-5812.

About the Drug Information Association (DIA)
The Drug Information Association serves more than 18,000 professionals in the biotechnology, pharmaceutical and regulatory industries worldwide. Through its domestic and international meetings, training courses, workshops and webinars, DIA provides a neutral global forum for the exchange of information critical to the advancement of the drug discovery and lifecycle management processes. Headquartered in Horsham, Pa., USA, and with offices in Basel, Switzerland and Tokyo, Japan, the Association is led by its volunteer-based board of directors and executive management team. For more information, visit www.diahome.org or call 215-442-6100.

SOURCE: Drug Information Association