Let

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Lets talk smart!

• Robert A. Yetter, Ph.D.
• Associate Director for Review Management
• CBER, FDA

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How to Use Meetings to Your Advantage and to
FDAs!

• Why meet?
• When do you meet?
• How do you meet?
• Whats the meat in the meet?
• When are meetings wasted?

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Why Meet?

• Obtain FDA advice and direction
• Clarify procedures
• Clarify expectations
• Resolve disputed issues

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No Need to Meet To

• Introduce new staff
• Introduce CEO
• Introduce product
• Not a show tell opportunity

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When Should We Meet?

• Meet early before youre committed to a final
  action
• Pre-IND
• End of Phase2/Pre-Phase 3
• Take advantage of the Special Protocol
  Assessment
• Pre-BLA
• Disputes stalling product development

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Types of Meetings
Type Description FDA Timeframe Package Due
A Critical path for stalled drug development 30 days 2 weeks before meeting
B Pre-IND End Phase 2 Pre-BLA 60 days 4 weeks before meeting
C All others 75 days 4 weeks before meeting
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FDA PDUFA II Timelines for Meetings

• Process Meeting Request
• 14 days from receipt of request
• Hold Meeting
• 30(A), 60 (B), or 75 (C) days from receipt of
  request
• Issue Meeting Minutes
• 30 days from meeting date

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The Telephone Is a Good Thing -

• Consider a telephone conference instead of a
  face-to-face
• Easier to schedule
• Cheaper for you
• Better access to staff
• Who can FDA talk to?

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How Do You Request a Meeting?

• Before calling or writing, read the meeting
  guidance!
• Formal Meetings with Sponsors and Applicants for
  PDUFA Products http//www.fda.gov/cber/gdlns/mt
  pdufa.pdf
• CBER SOPP Scheduling and Conduct of Regulatory
  Review Meetings with Sponsors and Applicants
  February, 1999

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The Meeting Request

• Product and Indication
• Type of meeting
• Purpose of meeting
• Specific objectives expected
• Proposed agenda
• Specific questions
• Sponsor attendees
• Requested FDA attendees
• Date meeting package to be submitted
• Suggest meeting dates and times (we recommend 3
  dates)

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The Meeting Meat Package

• Product Information
• Name, chemical name and structure
• Proposed indication
• Dosage form, route of administration, and dosing
  regiment
• Data summaries
• Pre-clinical data
• Clinical data
• Chemistry, manufacturing and controls

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For a Successful Meeting - Do

• Provide a brief background summary
• Assume the meeting package has been read
• Show how study fits overall development plan
• Focus on questions
• Limit your presentation
• Summarize agreements/disagreements
• Bring hardcopy of slides for RPM

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Please, Dont -

• Regurgitate the meeting package
• Expect FDA to guess your critical issues
• Request a pre-BLA before pivotal trial results
  shown to demonstrate efficacy
• Present issues outside proposed agenda
• Send new data just before meeting
• Expect evaluation of new data presented at
  meeting

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After the Meeting -

• Review agreements
• Request FDA minutes of meeting
• Notify FDA of any differences
• Follow through

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Remember that meeting package?

• The meeting package must
• Include sufficient information for meaningful
  discussion
• Be received by the due date
• If the above are not met,
• the meeting will be cancelled!

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Were Here to Help You!

• WWW.FDA.GOV/CBER
• Email CBER
• Manufacturers matt_at_cber.fda.gov
• Consumers, health care professionals
  octma_at_cber.fda.gov
• Phone [phone]
• Listserv http//www.fda.gov/cber/pubinfo/elists.
  htm

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Were Here to Help You!

• Contact me via phone at
• 301-827-0373
• Or contact me via e-mail at
• Robert.yetter_at_fda.hhs.gov