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OTP Pre-IND Meetings

Pre-IND meetings can be valuable for sponsors in procuring feedback on a sponsor’s product development program, especially if a sponsor’s questions are not fully answered by guidance documents and other publicly available resources. A pre-IND meeting can also provide information that will assist sponsors in preparing to submit complete investigational new drug (IND) applications and reduce the risk of a clinical hold. The primary purpose of this meeting is to review and obtain feedback on the design of preclinical studies, the design of the initial IND study, and product manufacturing and quality controls needed to initiate human studies. The meeting also provides an opportunity to discuss the  plans for studying the product in pediatric populations, the target product profile,  the quality target product profile, the design and results of any natural history studies, and the best approach for presentation and formatting of data in the IND.

Timing of Pre-IND Meeting Request

Sponsors are sometimes unsure whether to request an INTERACT or pre-IND meeting for the current state of development of their product. See INTERACT Meeting Section for information regarding INTERACT meetings.  In general, a pre-IND is the appropriate meeting type if:

  • The sponsor has defined the manufacturing process to be used for the clinical studies and has developed assays and preliminary lot release criteria.
  • The sponsor has completed proof-of-concept (POC) and possibly some preliminary preclinical safety/toxicology studies and desires to move to the definitive toxicology studies
  • The sponsor’s questions involve IND-enabling Chemistry, Manufacturing, and Controls (CMC), pharmacology/toxicology (P/T), and/or clinical trial design issues.

Process for requesting a pre-IND meeting

Sponsors may email meeting requests to cberdcc_emailsub@fda.hhs.gov, with OTPRPMS@fda.hhs.gov in cc line for Regulatory Management Staff awareness.  The meeting request should include a list of the specific objectives of the meeting and a list of questions (grouped by disciplines, e.g., CMC, P/T, clinical). To ensure that the appropriate FDA staff are assigned to the meeting, the meeting request should include draft questions. Draft questions submitted in the meeting request can be refined with the submission of the meeting package.

OTP does not send an acknowledgement email or letter following OTP’s receipt of the pre-IND meeting request. However, as denoted in the table below, by Day 21, OTP will send the decision to grant or deny the meeting request, along with the meeting date, if granted, or reasons for denial. OTP will provide the sponsor with a pre-submission tracking number (PTS) with the meeting confirmation.

The pre-IND meeting will be scheduled to occur within 60 days of receipt of the meeting request.

OTP schedules Pre-IND meetings for 60 minutes.

Pre-IND meetings are Type B meetings, and follow the timelines FDA had established for Type B meetings. For additional information on meeting types, refer to Formal Meetings Between the FDA & Sponsors or Applicants of PDUFA Products Guidance for Industry.

Table: Timelines for Pre-IND (Type B) Meetings

OTP Response to Meeting Request** 21 days
Meeting Scheduled or WRO issued*** 60 days
Meeting package due to OTP At least 30 days before the scheduled date of the meeting or WRO
Meeting Length 60 minutes
OTP Preliminary Response to questions in the package to Sponsor (for teleconferences) NLT* 2 days before the meeting
Sponsor’s Response to FDA preliminary response (for teleconferences) NLT than 24 hours before the meeting

*NLT – No Later Than
Source: Table information from the Formal Meetings Between the FDA & Sponsors or Applicants of PDUFA Products Guidance for Industry
**Calendar days from FDA receipt of the meeting request to the date that OTP will respond with the decision to grant or deny the meeting, as well as specifying the format and date of the meeting, if granted.
*** Calendar days from FDA receipt of the meeting request to date the meeting will be held, or the WRO will be issued. 

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