Briefing Package and Health Authority Feedback

Question 1

What types of meetings does a project team usually have with health authorities related a filing?

Answer 1

With the FDA, content-format meetings and pre-NDA/pre-BLA meetings; with EMA, pre-submission meetings.

Question 2

What is the purpose of the pre-NDA/pre-BLA/pre-submission meetings?

Answer 2

The purposes of these meetings are to obtain procedural, regulatory and legal advice from HAs and to mitigate possible validation problems, and to obtain information that will assist in the finalization of the upcoming application including the addition of any final input received from HAs.

Question 3

When will the HAs provide feedback following the pre-NDA/pre-BLA/pre-Submission meetings?

Answer 3

HA feedback after pre-filing BP/HA meeting generally occurs during preparation and review of Module 2 documents. Sometimes it can occur late in the process when the documents are almost fully reviewed.

Question 4

Which function is responsible for overall strategy and deliverables for HA interactions?

Answer 4

PDR PM

Question 5

What are some of the best practices in preparing the briefing packages?

Answer 5

Before the writing of BP starts, draft the questions, prepare the outline of company positions, and for high priority BPs one, team may consider further front-loading.