Module 5 Presentations

18/07/2024

Initial Timelines for Pre-IND and IND

Pre-IND Meeting

File IND

IND Cleared

Clear

requestbrief meet

lock file

Approx. 3 wk

30 d 30 d

30 d

P

Questions

FDA comments

P

Briefing book

FDA comments

P

FDA Review

Prepare IND

P = Publishing

The Organisation for Professionals in Regulatory Affairs

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Types of Meetings*

Type

A

B

B (EOP)

C

Confirmation

14 days

21 Days

14 days

21 days

Held no later than 30 days from request

30 days

60 days

70 days

75 days

Briefing package

With meeting request

30 days before Pre-IND Pre-NDA

50 days before

47 days before

Description

• Dispute resolution • Clinical hold • Special Protocol Assessment (SPA)

EOP1 EOP2/pre Phase3

Any other (not Type A and not Type B)

*Meetings with FDA for biosimilar/generic/OTC products fall under separate guidances and timelines.

The Organisation for Professionals in Regulatory Affairs

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