1. Associate Director for Review Management
Let’s talk smart!
Robert A. Yetter, Ph.D.
Associate Director for Review Management
CBER, FDA
Communication with the FDA - Yetter

2. How to Use Meetings to Your Advantage – and to FDA’s!
Why meet?
When do you meet?
How do you meet?
What’s the meat in the meet?
When are meetings wasted?

3. Why Meet? Obtain FDA advice and direction Clarify procedures
Clarify expectations
Resolve disputed issues

4. No Need to Meet To: Introduce new staff Introduce CEO
Introduce product
“Not a show & tell opportunity”

5. When Should We Meet?
Meet early before you’re 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

6. 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

7. 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

8. 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?

9. How Do You Request a Meeting?
Before calling or writing, read the meeting guidance!
Formal Meetings with Sponsors and Applicants for PDUFA Products
CBER SOPP Scheduling and Conduct of Regulatory Review Meetings with Sponsors and Applicants: February, 1999

10. 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)

11. 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

12. 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

13. Please, Don’t - 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

14. After the Meeting - Review agreements Request FDA minutes of meeting
Notify FDA of any differences
Follow through

15. 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!

17. We’re Here to Help You! Manufacturers: matt@cber.fda.gov
CBER:
Manufacturers:
Consumers, health care professionals:
Phone: /
Listserv:

18. We’re Here to Help You! Contact me via phone at: 301-827-0373
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