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

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?

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

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

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

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

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

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?

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/mtpdufa.pdf CBER SOPP Scheduling and Conduct of Regulatory Review Meetings with Sponsors and Applicants: February, 1999

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)

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

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

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

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

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!

We’re Here to Help You! Manufacturers: matt@cber.fda.gov 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

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