Usage Examples
- The Pre-Sub package goes out a month before the meeting, so the endpoint decision has to be locked next week.
- FDA's Pre-Sub feedback supported the predicate, but they want bench data we have not generated yet.
- That agreement never made it into the minutes, so we are still treating the endpoint as open.
What is Pre-Submission Meeting?
Pre-Submission Meetings are formal, sponsor-requested meetings with FDA held before an application is filed, securing agency feedback on study design, evidence standards, and submission content while the plan can still change rather than after review begins.
Pre-Submission Meetings exist because the costly mistakes in a development programme are made before anything is filed: the wrong endpoint, the wrong comparator, the wrong evidence standard. FDA's meeting regulations move that conversation earlier, treating a meeting with the agency as the mechanism for resolving questions raised during a clinical investigation while the protocol can still be changed and the money has not been spent.
Pre-Submission Meetings cover the plan, not the product. In scope: study design and endpoints, the nonclinical package, evidence standards, submission format and content, pediatric plans, and the regulatory pathway. Out of scope: any review of a completed application, any commitment to approve, and any position on data the sponsor has not generated yet. A Pre-Sub settles the question, never the verdict.
Pre-Submission Meetings are run as a written exercise with a meeting attached. The sponsor files a background package at least one month ahead, FDA answers the specific questions asked, and agreements reached are recorded in the minutes of the conference. Broad questions return broad answers, so each question should carry the sponsor's own proposed position and the data standing behind it.
Not to be confused with
- Pre-NDA / pre-BLA meeting
- a specific meeting type defined at 21 CFR 312.47(b)(2), held to uncover major unresolved problems immediately before a marketing application. "Pre-Submission Meeting" is the general category; the pre-NDA meeting is one instance of it at one fixed point in the drug lifecycle.
- Pre-IND meeting
- held under 21 CFR 312.82(a) before the initial IND exists, chiefly to agree the animal study designs needed to begin human testing. It sits ahead of all clinical work, whereas most Pre-Subs sit between phases or immediately before a marketing application.
- Determination meeting (devices)
- a statutory meeting FDA must grant on written request from a prospective PMA applicant under FD&C Act 513(a)(3)(D), and whose specification of valid scientific evidence binds the Secretary unless it could be contrary to the public health. Ordinary Pre-Sub feedback carries no such binding effect.
- Meeting minutes
- the minutes are the record of what was agreed, not the meeting itself. Under 21 CFR 312.47(b)(1)(v) agreements reached are recorded in the minutes of the conference, so an understanding that never reached the minutes is not an agreement.
The obligations attach to the package and the record, not to the conversation.
What you must do
- 1Send FDA the background information at least one month before an end-of-Phase 2 meeting, covering the Phase 1 and 2 summaries, the Phase 3 protocols, nonclinical study plans, tentative labeling, and pediatric study plans with a timeline for protocol finalization, enrollment, completion, and data analysis21 CFR 312.47(b)(1)(iv)
- 2Confirm that every agreement reached at the meeting appears in the minutes of the conference, because the minutes are the record the programme will be held to later21 CFR 312.47(b)(1)(v)
- 3Use the pre-NDA or pre-BLA meeting to surface major unresolved problems and to identify the studies being relied on as adequate and well-controlled, submitting the supporting information at least one month ahead21 CFR 312.47(b)(2)
- 4Request a pre-IND meeting before the initial IND is submitted while the animal study designs needed to support human testing are still open21 CFR 312.82(a)
- 5For a device heading to PMA, make the request for a determination meeting in writing, since the written request is what obliges FDA to meet and what makes the resulting evidence specification binding on the agencyFD&C Act 513(a)(3)(D)
Common mistakes
Asking FDA open-ended questions
"Does the agency agree with our approach?" invites a non-answer. FDA responds to the questions as asked, so a question that carries no proposed position of the sponsor's own returns feedback you cannot build a protocol or a submission against, and the meeting slot is spent.
Treating the package as paperwork and the meeting as the deliverable
the background information is due at least one month ahead under 21 CFR 312.47(b)(1)(iv) and is what the review division actually reads. A thin package produces thin written feedback, and the meeting is then consumed by clarification instead of decisions.
Relying on a verbal agreement that never reached the minutes
21 CFR 312.47(b)(1)(v) makes the minutes of the conference the record of agreements reached. A recollection of what a reviewer said in the room, absent from the minutes, will not hold at the pre-NDA meeting or during review, and re-litigating it costs a review cycle.
When This Matters
- The Pre-Sub package goes out a month before the meeting, so the endpoint decision has to be locked next week.
- FDA's Pre-Sub feedback supported the predicate, but they want bench data we have not generated yet.
- That agreement never made it into the minutes, so we are still treating the endpoint as open.
Frequently Asked Questions
Usually no, with one statutory exception. For a device heading to PMA, FD&C Act 513(a)(3)(D)(v) makes FDA's specification of the valid scientific evidence needed binding upon the Secretary unless it could be contrary to the public health. On the drug side, outcomes are agreements recorded in meeting minutes, not law.
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Sources & References
- 21 CFR 312.47 - Meetings (CFR full text)
- 21 CFR 312.82 - Early consultation (CFR full text)
- 21 U.S.C. 360c - Classification of devices intended for human use (FD&C Act sec. 513)
- 21 CFR 10.65 - Meetings and correspondence (CFR full text)
- FDA - Q-Submission and Early Payor Feedback Request Programs and Medical Device Development Tools (Federal Register notice, 18 Feb 2026)
