FDA’s New RDEP: Not Just Clinical Data Matters
By Dr. Nathalie Machluf | October 2025
FDA’s New RDEP: Not Just Clinical Data Matters
By Dr. Nathalie Machluf | October 2025
FDA’s New RDEP: Not Just Clinical Data Matters
By Dr. Nathalie Machluf | October 2025
FDA Pre-IND Meeting: Not Just a Checkbox — A Strategic Tool to Reduce Time to Market
By Dr. Nathalie Machluf | March 2026
Early drug development is a critical phase in which key scientific and regulatory decisions can significantly influence the overall development program. Among the early regulatory interactions available to sponsors, the pre-IND meeting with the U.S. Food and Drug Administration (FDA) represents a particularly important strategic regulatory milestone.
3 Strategic Objectives
This meeting should not be viewed as a procedural formality. When approached strategically, the pre-IND meeting should aim to achieve three key outcomes:
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1. Confirm development readiness
Ensure that integrated nonclinical, translational, and CMC programs have generated (or will generate through planned studies) a sufficiently robust package to support first-in-human clinical evaluation.
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2. Evaluate the Phase I study design
Discuss the starting dose, escalation strategy, and safety mitigation measures within the context of the overall clinical development plan.
3. Clarify the regulatory pathway
Obtain feedback from the FDA on development strategy, regulatory expectations, and potential pathways that could facilitate development.
When properly prepared and strategically framed, the pre-IND meeting can provide substantial value to sponsors by clarifying regulatory expectations and strengthening the overall development strategy. In particular, a well-prepared pre-IND meeting enables sponsors to:
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Validate the scientific rationale — Confirm that clinical development is supported by robust scientific evidence.
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Ensure decision-enabling studies — Help planned studies generate meaningful data.
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Identify potential vulnerabilities early — Detect gaps or weaknesses before they affect development timelines.
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Reduce clinical hold probability — Proactively resolve regulatory questions and gaps to prevent holds during IND review.
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Obtain clear and actionable FDA feedback — Confirm alignment on clinical and regulatory expectations for the intended indication in the target population.
As a result, the likelihood of a successful IND review outcome is increased, reducing the risk of unnecessary development delays and supporting an optimal program trajectory.​​
5 Key Benefits for Sponsors​​
4 Common Risk Areas​
While preparing for a pre-IND meeting, sponsors should also be aware of common issues frequently raised during these interactions. Typical concerns include:
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CMC uncertainties — Process reproducibility, product comparability, or analytical testing issues
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Insufficient nonclinical support — Data gaps affecting the safety rationale for first-in-human exposure.
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Weak starting dose justification — Inadequate rationale for dose selection or escalation scheme.
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Clinical trial design concerns — Study population, endpoints, safety monitoring, or stopping rules.
Paying close attention to these aspects when planning and preparing for a pre-IND meeting ensures productive discussions and fosters a collaborative relationship with the regulator, based on scientific rigor and mutual trust.​​
CONCLUSION
​The pre-IND meeting is the first major checkpoint for regulatory and scientific alignment with the FDA, laying the foundation for a successful short- and long-term development strategy and supporting efficient program execution to achieve timely market access.
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