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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: matt@cber.fda.gov–Consumers, health care professionals: octma@cber.fda.gov

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:

Robert.yetter@fda.hhs.gov