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It is impossible to anticipate how many presubmissions may be required before the initial IND application is submitted.However, using 9990–9999 is not recommended for the following reasons: Several large eCTD vendors seemed to follow a common practice of submitting the pre-IND meeting request as sequence 9998 and the briefing book as sequence 9999. There has been some debate in the industry as to whether a presubmission submitted in eCTD format should use an eCTD sequence number of 0000, 9990, or something else. The initial IND is required to be numbered 000 each subsequent submission (e.g., amendment, report, or correspondence) is required to be numbered chronologically in sequence. This was the preferred method because the four-digit eCTD sequence number would match the three-digit IND serial number, which is required per 21 CFR 312.23(e):Įach submission relating to an IND is required to be numbered serially using a single, three-digit serial number. The initial IND application would then be submitted in eCTD format, as eCTD sequence number 0000. In the past, small- to mid-sized sponsors would typically submit a Type B pre-IND meeting request (and its associated meeting package, also known as a briefing book) in paper format under a pre-assigned PIND number. Not all applications will have presubmissions.

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The US Module 1 Specification (Version 1.3, December 2006) for us-regional DTD v2.01 defines a presubmission as “information submitted prior to the submission of a complete new application.” This definition was expanded upon in the new US Module 1 Specification (Version 2.3, February 2014) for us-regional DTD v3.3 as follows:Ī submission to the Agency that occurs prior to the actual submission of a full application (e.g., rolling review, reviewable unit, clinical information that the applicant requests comment on prior to submitting their application). These types of submissions are known as “presubmissions” and are becoming increasingly common.

Before an original application (such as an initial IND) is submitted, a sponsor may choose to submit correspondence to the application in eCTD format.