Maximizing FDA Meetings: Tips for Success

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

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

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 aMeeting? Before calling or writing, read the meeting guidance! Formal Meetings with Sponsors and Applicants for PDUFA Productshttp://www.fda.gov/cber/gdlns/mtpdufa.pdf 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! WWW.FDA.GOV/CBER • Email CBER: • Manufacturers: matt@cber.fda.gov • Consumers, health care professionals: octma@cber.fda.gov • Phone: 800-835-4709/301-827-1800 • Listserv: http://www.fda.gov/cber/pubinfo/elists.htm

18. We’re Here to Help You! • Contact me via phone at: 301-827-0373 • Or contact me via e-mail at: Robert.yetter@fda.hhs.gov