# Presentation: 778180

## Let’s talk smart!

**Robert A. Yetter, Ph.D.**
**Associate Director for Review Management**
** ****CBER, FDA**

## 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 | 4 weeks before meeting |

## 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!

## Slide 16

## 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

## 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