1 let’s talk smart! robert a. yetter, ph.d. associate director for review management cber, fda
TRANSCRIPT
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Let’s talk Let’s talk smart!smart!
Robert A. Yetter, Ph.D.
Associate Director for Review Management
CBER, FDA
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How to Use Meetings to Your How to Use Meetings to Your Advantage – and to FDA’s!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?
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Why Meet?Why Meet?
Obtain FDA advice and directionClarify proceduresClarify expectationsResolve disputed issues
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No Need to Meet To:No Need to Meet To:
Introduce new staffIntroduce CEOIntroduce product
“Not a show & tell opportunity”
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When Should We Meet?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
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Types of MeetingsTypes of MeetingsType Description FDA
TimeframePackage 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 FDA PDUFA II Timelines for MeetingsMeetings
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 The Telephone Is a Good Thing -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 aHow Do You Request a Meeting?Meeting?
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
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The Meeting RequestThe 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] PackageThe 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 For a Successful Meeting - DoMeeting - Do
Provide a brief background summaryAssume the meeting package has been readShow how study fits overall development planFocus on questionsLimit your presentationSummarize agreements/disagreementsBring hardcopy of slides for RPM
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Please, Don’t - 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
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After the Meeting - After the Meeting -
Review agreementsRequest FDA minutes of meetingNotify FDA of any differences Follow through
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Remember that meeting package?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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We’re Here to Help You!We’re Here to Help You!WWW.FDA.GOV/CBER
Email CBER:–Manufacturers: [email protected]–Consumers, health care professionals: [email protected]
Phone: 800-835-4709/301-827-1800Listserv:
http://www.fda.gov/cber/pubinfo/elists.htm
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We’re Here to Help You!We’re Here to Help You!
Contact me via phone at:
301-827-0373
Or contact me via e-mail at: