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U.S. Department of Health and Human Services

For Industry

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Appendix D: Applicant Interview Guide

Planned Review Timelines Assessment: Table of Contents

Assessment of Planned Review Timelines: Root Cause Analysis
Interview Guide for Applicants

1) Is your company aware of the new planned review timeline requirements as mandated by FDAAA which requires FDA to
a. notify sponsors via the 74-day letter of the timeframe by which labeling and/or PMR/PMC discussions will be initiated?

b. begin labeling and/or PMR/PMC discussions by the indicated timeframe?

2) Has implementation of the planned review timelines impacted your company’s processes for preparing submissions to FDA?

a. If so, how?

3) Do discussions with FDA regarding labeling, PMR/PMCs, and/or REMS begin during the timeframe indicated to your company by FDA in the 74-day filing communication letter?

4) Do you ensure that your company’s labeling submissions are complete or finalized for FDA review by these dates?

a. What actions are taken by your company to ensure timely completion/finalization of labeling submissions?

b. What actions are taken by your company when preparing labeling submissions to minimize further FDA information requests and need for data?

5) What factors prevent your company from being able to finalize/complete labeling by the date when discussions are supposed to begin with FDA?

6) How do you decide what data to include in or exclude from your application?

7) Are there any processes that your company takes to ensure that FDA has adequate time to review and finalize labeling and PMR/PMCs? If so, please describe?


Planned Review Timelines Assessment: Table of Contents