• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Drugs

  • Print
  • Share
  • E-mail

Best Practices for Effective and Productive VXDS Meetings

VXDS meetings are most effective when submitters keep in mind that these meetings are scientific and non-binding, and that any regulatory advice on the development of a particular drug or diagnostic should go through the proper regulatory mechanism (e.g., CDER, CBER, or CDRH review divisions). Should aspects of the subject matter discussed in VXDS submissions become part of a regulatory submission (e.g., IND, NDA, or BLA), it is at the full discretion of the appropriate review staff to completely and independently assess the sponsor's application.

Once you decide to request a meeting

  • Determine the intended scope of the meeting prior to contacting the VXDS program
  • Determine whether you would like to have a joint VXDS with FDA (US), EMA (EU), and/or PMDA (Japan).
  • Request a meeting by contacting the person at the bottom of this page. When contacting us, please be prepared to describe:
    • The intended scope of the meeting
    • Requested list of FDA attendees (Optional)
    • A list of questions or discussion points for the Interdisciplinary Scientific Exchange Group (ISEG)
  • Be prepared to send a background package with presentation materials shortly after initial contact (typically two weeks after your request is acknowledged)
  • Remember that a VXDS is a voluntary exploratory data submission; therefore, inclusion of raw data for reanalysis or alternative analyses by the ISEG is not mandatory but highly desirable and encouraged

Background is extremely important

  • A background package should typically include:
    • Scope of the meeting
    • Agenda
    • Presentations
    • List of attendees
    • Data
    • Specific VXDS questions or discussion points for the ISEG's consideration
  • You may contact the person at the bottom of this page for a sample template that may be used in preparing the background package

Presentations Should

  • Be short and to the point
  • Leave time for discussion
  • Focus on scope of meeting and your questions or talking points
  • Keep company history to a minimum and make relevant to agenda

During Meeting

  • Stick to the designated scope and questions
  • Limit meeting to 1 hour for presentation, questions, responses, and action items
  • Start and end on time
  • Be open to discussion with FDA
  • Get action items reiterated or recapped at the end of the meeting

Avoid

  • Requesting meeting before you have adequate information and data ready to discuss
  • Providing new information at the VXDS meeting not included in background package, or sending new information just before meeting
  • Having side discussions before, during or after meeting – stick to agenda and timeframe
  • Requesting concurrence on clinical protocols or  clinical studies for approval of an application

General Advice

  • Keep meeting informal
  • Provide several options for dates when scheduling – be flexible
  • If you have to cancel a meeting, do so at least 48 hours in advance; earlier is preferred

After the Meeting

  • The VXDS program does not provide meeting notes, minutes, or a summary of talking points as this is intended to be an informal meeting. Submitters may feel free to capture their own version of the discussion, but these will not be endorsed by FDA as an official meeting summary
  • FDA scientists are always interested in scientific collaboration where appropriate; follow-up actions may include joint publications between ISEG members and submitters of VXDS where appropriate (see Nature Reviews Drug Discovery 9, 435-445 (June 2010) as example)
  • The VXDS program may contact VXDS submitters in the future to assess submitters' experiences with the VXDS program

Contact VXDS Interdisciplinary Scientific Review Group (ISEG), Chair

Issam Zineh, PharmD, MPH, Associate Director for Genomics, Office of Clinical Pharmacology, US Food and Drug Administration, Tel: (301) 796-4756 or Email: Issam.Zineh@fda.hhs.gov