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In today’s regulatory climate, reports of staffing shortages and slowed review timelines at the FDA have sparked anxiety across the biopharma industry — especially for sponsors preparing for key submissions like INDs or NDAs. At Veristat, however, our recent experiences paint a very different picture.
“Across multiple meetings and divisions, FDA has been responsive, punctual, and collaborative,” says John Kirk, Principal Regulatory Strategist at Veristat. “In fact, the past few weeks have reaffirmed how effective well-prepared FDA meetings — supported by strong strategy and scientific writing — can be.”
👉 FDA Meetings: What We’re Seeing at Veristat Right Now
Veristat has supported several recent FDA interactions across different formats and meeting types, each reinforcing that effective engagement remains possible and productive.
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Type A Meeting – In-Person
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Veristat supported a sponsor in a high-stakes Type A meeting with FDA to address a clinical hold. These urgent situations require both strategic clarity and deep scientific expertise. Veristat attended the meeting alongside the sponsor, guiding discussions around complex safety and efficacy data. Thanks to focused preparation and clear communication, the outcome was constructive: FDA provided a defined path forward to resolve the hold and continue development.
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Type C Meeting – Teleconference
In this case, Veristat participated in a recent Type C meeting where a sponsor proposed changing the primary endpoint of an active Phase 2 study — a complex and potentially sensitive request. Our team helped develop the scientific rationale, prepared the briefing materials, and joined the teleconference to support the discussion. FDA responded constructively, and the meeting concluded with clear alignment and agreement to move forward — a strong example of effective collaboration.
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Meeting Denial – with Direction
Not every meeting request leads to a formal interaction — and that’s not necessarily negative. When FDA denied one recent request, the Agency explained that the sponsor’s questions were already well-addressed in existing guidelines and encouraged submission of the IND. That kind of clear guidance, even without a meeting, helped the sponsor stay on track.
“We’re seeing that the system is still working,” noted John. “Timelines are being met, and when sponsors are prepared and intentional in their approach, the outcomes are constructive.”
👉 Meeting Types and Timelines: Staying Aligned with FDA Expectations
Understanding FDA’s meeting types — and their distinct timing windows — is key to successful planning:
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Type A Meetings (urgent issues like clinical holds): Held within 30 days of request
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Type B Meetings (milestones like Pre-IND, End-of-Phase 2, or Pre-NDA): Held within 60 days
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Type C Meetings (targeted topics or development questions): Held within 75 days
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Type D Meetings (narrow scope with focus on a single topic): Held within 50 days
Veristat ensures that each meeting request is based on clear objectives and that each briefing package is delivered with the right scientific framing and regulatory alignment.
👉 What Makes the Difference? Preparation, Clarity, and Communication
Much of what makes these interactions successful comes down to clarity — in both documentation and dialogue.
“Excellent writing is foundational,” John Kirk notes. “You have to be factual, succinct, well-referenced, and aligned with what the FDA needs to see. That’s not just about compliance — it’s about advancing the discussion in a productive way.”
Veristat’s regulatory team is deeply experienced in the strategy, logistics, and communication skills that make agency interactions effective. From early-stage meetings to more complex post-approval discussions, we help sponsors navigate each step with focus and precision.
👉 Looking Ahead: FDA Remains Responsive
While concerns about delays — especially for marketing applications — remain in circulation, our experience shows that for INDs, ongoing clinical programs, and early-phase engagements, FDA remains responsive.
John observed, “We’ve seen that when meetings are requested appropriately and supported with clear rationale, FDA is still delivering. Whether the meeting is granted or not, there’s direction and engagement — and that helps our sponsors keep moving forward.”
👉 Let’s Talk About Your Next Discussion with FDA
Whether you’re preparing for your first Pre-IND meeting, seeking guidance on trial modifications, or addressing a clinical hold, Veristat is ready to help. We work collaboratively with sponsors and FDA to ensure regulatory progress stays on track — even in times of uncertainty.
Reach out today to discuss how Veristat can support your next FDA milestone, click here:
Learn More:
Staying the Course: What FDA Staffing Reductions Mean for Drug Development Today
FDA Meeting Types: Timing, Purpose & Examples of Type A, B & C Meetings with CDER and CBER
John Kirk
Principal Regulatory Strategist
John Kirk, ScD, MS, is a Principal Regulatory Strategist at Veristat with over 30 years of experience in Regulatory Affairs, supporting global clients from early development through marketing authorization and post-approval. He specializes in rare diseases and helps align regulatory strategies with agency expectations and patient needs.
John has held senior roles at Amicus Therapeutics, Millendo Therapeutics, and Aegerion Pharmaceuticals, leading global regulatory activities including NDA, MAA, and post-marketing submissions. He has also provided regulatory consulting for emerging biotechs, supporting orphan designations and regulatory pathways.
John holds a BS in Biological Sciences, an MS in Chemistry, and a ScD in Outcomes Research from Tulane University.
John has held senior roles at Amicus Therapeutics, Millendo Therapeutics, and Aegerion Pharmaceuticals, leading global regulatory activities including NDA, MAA, and post-marketing submissions. He has also provided regulatory consulting for emerging biotechs, supporting orphan designations and regulatory pathways.
John holds a BS in Biological Sciences, an MS in Chemistry, and a ScD in Outcomes Research from Tulane University.