Nonclinical Questions? When to Request an FDA Meeting

Should You Meet With FDA About Your Nonclinical Safety Data?

By Dr. Bill F. Hodnick, DABT and Dr. Jerry Bettis, DABT

Teams overseeing nonclinical studies often reach a point where the toxicology data raises more questions than certainties, and it’s not obvious whether those questions are worth bringing to the U.S. Food and Drug Administration (FDA). Getting that timing right can shape a program’s entire development strategy.

Depending on the R&D stage your team is in, you may be asking:

• Should I meet with FDA to talk about my nonclinical development plan?
• Are certain meetings more helpful than others when the open questions are about toxicology or safety data?
• When is an FDA meeting not worth the cost and effort?
• How can I increase the odds of a successful nonclinical meeting with FDA?

You don’t need to wait for a formal reason to talk to FDA about your nonclinical development plan and to raise toxicology questions early. A pre-IND meeting with the FDA is also an excellent way to get to know your review team, surface their concerns about your product early, and get them invested in helping champion your program toward approval. With rare exception, the benefits of an FDA meeting far outweigh the costs.

What the Data Says About Early FDA Engagement

The case for early engagement isn’t just anecdotal. Vu and Pariser (2015) found that during FYs 2008–2012, applications that included a pre-Investigational New Drug (IND) meeting during development (n=49) had shorter clinical development times (median = 6.4 years) than applications without one (n=83, median = 8.3 years).

Meetings at every stage of development can move a product forward. But if your primary goal is FDA approval, the evidence suggests the most valuable meetings tend to happen earliest, when nonclinical and toxicology questions are still open and the regulatory pathway isn’t yet established.

The Purpose of a Pre-IND Meeting

Pre-IND meetings exist to answer critical questions about nonclinical safety, efficacy, and what’s required before moving into human studies. They’re particularly valuable for:

• New chemical entities
• Novel indications for unmet medical needs
• Orphan drug products
• Biologics, where the regulatory pathway is less charted and aspects of the clinical program (like efficacy endpoints) are still uncertain

Pre-IND meetings aren’t the only venue where nonclinical questions surface. Toxicology and safety data can also come up at Type B or Type C meetings, or even earlier at an INTERACT meeting for novel modalities or programs on an unusual development path seeking preliminary FDA feedback. But for open nonclinical questions early in development, while there’s still time to build FDA’s feedback into the study design, a pre-IND meeting is typically the most direct venue.

Related Reading: What are the Different FDA Meeting Types for Drugs and Biologics?

Four Factors That Determine Whether a Nonclinical Meeting Succeeds

1. Purpose

Before requesting a meeting, consult the FDA’s guidance: Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products (2026). It describes meeting types and the regulatory basis for each.

Then ask yourself:

• Do we genuinely need FDA’s thinking here?
• Do existing guidance documents, FDA presentations, or precedent (like Summary Bases of Approval (SBAs) from approved products with similar indications) already answer it?
• Would an answer from the FDA actually change the development plan?

If there are no real questions that need FDA input, don’t request a meeting. Meetings are labor-intensive for sponsors and FDA alike and should only happen when genuine dialogue is needed.

If you determine FDA input would be impactful, make sure the questions match the stage. Asking about NDA format and content in a pre-IND meeting when a submission is 10+ years away, for example, leads to frustration on both sides of the table.

If any of this is unclear, a regulatory affairs expert can help sort it out. Remember that every interaction with reviewers shapes their impression of your program and your product so make them count.

2. Timing

An FDA meeting is unlikely to succeed if there isn’t enough runway left to act on the guidance. Planning carefully and building in enough time to hear FDA’s feedback, decide on a path forward, and execute against it enables sponsors to benefit most from an FDA meeting.

Related Reading: Navigating Pre-IND Meetings: A Strategic Guide

3. Preparation

Preparation is crucial to meeting success and includes a well-conceived meeting request, a concise background package, and flawless execution during the meeting itself. Contrary to popular opinion, a successful FDA meeting isn’t one where reviewers agree to everything asked. Success means getting clear answers to the questions raised and having a clear path forward. Poorly prepared questions invite ambiguous answers, and a disorganized background package can confuse reviewers and derail the discussion. Every speaking role should be scripted and rehearsed so the dialogue stays focused on clear takeaways.

Leave room for FDA to offer unsolicited input, too. Vu and Pariser (2015) found that 44% (n=32) of 73 pre-IND meeting minutes they reviewed included additional FDA comments on topics the sponsor hadn’t raised, spanning clinical (78%), CMC (44%), regulatory (25%), and nonclinical (22%) topics. That kind of unprompted, critical feedback can meaningfully change how you develop a product or build an application.

Related Reading: FDA Nonclinical Requirements for Radiopharmaceutical Drugs: Diagnostic vs. Therapeutic Pathways

4. Acceptance of Guidance

One of the simplest ways to improve the odds of success is to take FDA’s feedback seriously: understand the issue, treat it as real, and take concrete steps to resolve it. You can follow FDA’s suggested path or propose an alternative, but following up to confirm FDA agrees the issue has been adequately addressed substantially increases the probability of long-term success.

Early FDA Dialogue Done Right Benefits Everyone

FDA has said, in numerous forums, that meetings exist for the sponsor. But the agency benefits too: a well-prepared meeting builds shared expectations between the sponsor and the review team and gives both sides a clearer, faster path forward.

A well-prepared pre-IND meeting doesn’t just answer today’s toxicology questions; it sets the tone for every interaction that follows.

Not confident in your FDA meeting strategy yet? Talk to an expert at Facet.

References

Vu HH & Pariser AR. Pre–investigational new drug meetings with the FDA: Evaluation of meeting content and characteristics of applications for new drug and biologic products. Therapeutic Innovation & Regulatory Science. 2015:49(3):434-442.

U.S. Food and Drug Administration. Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products: Guidance for Industry. Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, August 2026.

Jenkins L. & Wilson M. How to prepare well positioned meeting questions within a strategic background package. Global Forum. 2010:2(5):10-12.

Wilson M. & Jenkins L. How to make the most of your FDA meeting. Global Forum. 2010:2(1):8-10.