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Genomics
at FDA
Best Practices for Effective and Productive VGDS Meetings
Please keep in mind that the
views expressed in this document are the opinion of the members of
the Interdisciplinary Pharmacogenomics Review Group (IPRG) and may
not reflect the opinion of a review division. Therefore, the
provided answers should not be interpreted as regulatory guidance,
or review recommendations for an application, but as a scientific
assessment of the information presented. Should aspects of the
subject matter discussed herein become part of a non-voluntary data
submission, application, or supplement, it is at the full discretion
of the appropriate review division to completely and independently
assess the product(s) in question.
Once you decide to request a meeting
- Determine the scope of the meeting prior to
contacting IPRG
- Put request for meeting in writing and at
least 6 to 8 weeks prior to the proposed date and include:
- Scope of meeting
- List of sponsor attendees
- List of FDA attendees, if available
- Executive Summary
- List of VGDS questions
- Scientific issues
- Regulatory issues
- Be prepared to send background package with
presentation materials two weeks after request is acknowledged
- Remember that a VGDS is a voluntary genomic
DATA submission!
Background is extremely important
- Package should include:
- Scope of the meeting
- Agenda
- Presentations
- List of attendees
- Genomic data
- Specific VGDS questions IPRG is being
asked to address
- Avoid general questions like: βIs the
protocol ok?β
- Provide package at least 4 weeks prior to
meeting, or by date requested, in order for IPRG to fully prepare
for meeting
Presentations Should
- Be short and to the point
- Leave time for discussion
- Focus on scope of meeting and your questions
- Focus on issues at hand (scientific,
regulatory or administrative)
- Keep company history to a minimum and make
relevant to agenda
- Indicate where you are in product timeline
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
- Surprising IPRG at meeting with new
information not included in background package, or sending new
information just before meeting. Re-schedule instead.
- Having side discussions before, during or
after meeting β 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 β be flexible
- Begin meeting with an introduction of
attendees
- If you have to cancel a meeting, do so at
least 48 hours ahead
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Date created: March 22, 2005 |
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