Investigational New Drug Sponsors: Interviews

Surveys and Interviews with Investigational New Drug Sponsors to Assess Current Communication Practices with FDA Review Staff Under the Sixth Authorization of the Prescription Drug User Fee Act

Survey Instrument

Investigational New Drug Sponsors: Interviews

OMB: 0910-0863

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Sponsor Survey: Instrument

Instructions:

In completing this survey, please think about your recent Type [A/B/B EOC/C] meeting for IND [number].
All guidelines and requirements referenced in the questions pertain to:

Best Practices for Communication Between IND Sponsors and FDA During Drug Development Guidance for Industry and Review Staff (hereafter referred to as “communications guidance”)

and

Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products (hereafter referred to as “meetings guidance”).



FDA Guidances

  1. For this meeting, the meetings guidance was helpful in understanding:

Strongly Disagree

Disagree

Neutral

Agree

Strongly Agree

Don’t Know

Requirements for the meeting request.

O

O

O

O

O

O

Requirements for the meeting package.

O

O

O

O

O

O

What to expect during the meeting.

O

O

O

O

O

O




2. Comments on the meeting process:




Before the Meeting

3. In preparing for this meeting, we found that:

Strongly Disagree

Disagree

Neutral

Agree

Strongly Agree

Don’t Know

The required meeting package format was effective for communicating our questions/issues to FDA.

O

O

O

O

O

O

FDA’s preliminary comments were responsive to our questions/issues.

O

O

O

O

O

O

FDA’s preliminary comments clearly distinguished between regulatory requirements and advice.

O

O

O

O

O

O

Where appropriate, FDA’s preliminary comments directed us to specific regulations or guidance.

O

O

O

O

O

O



4. (Optional) Comments on communication processes and practices before the meeting:







The Meeting

5. From our perspective:

Strongly Disagree

Disagree

Neutral

Agree

Strongly Agree

Don’t Know

FDA staff who we requested, needed to answer our questions, were present.

O

O

O

O

O

O

FDA clearly distinguished between regulatory requirements and advice.

O

O

O

O

O

O

FDA directed us to specific regulations or guidance where appropriate.

O

O

O

O

O

O

This meeting was an effective means of addressing our questions/issues.

O

O

O

O

O

O



6. (Optional) Comments on communication processes and practices during the meeting:







Other Feedback

  1. What good practices contributed to a positive meeting planning and meeting experience?







  1. What challenges hindered the efficiency or effectiveness of the meeting process and meeting?







  1. What suggestions, if any, do you have for improving communication practices for IND meetings?







  1. (Optional) Other comments related to the meeting:







October 25, 2018 3

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