Guide
An IND readiness checklist is a structured pre-submission review across nonclinical, CMC, clinical protocol, starting-dose, and safety dimensions. It helps biotech and pharma teams surface gaps, anticipate FDA question areas, and prioritize remediation before the Investigational New Drug application goes in.
A complete checklist looks across the five review dimensions an FDA reviewer is likely to probe. Each dimension has expected evidence and common signals that a gap may exist.
| Dimension | Key items | Typical gap signals |
|---|---|---|
| Nonclinical | Pharmacology, PK/ADME, GLP toxicology | Incomplete species coverage, missing recovery arms |
| CMC | Drug substance, drug product, stability, analytics | Limited stability data, undefined impurity profile |
| Clinical protocol | Design, endpoints, eligibility, monitoring plan | Endpoints mismatched to mechanism or population |
| Starting dose | NOAEL/HED translation, MABEL where relevant | Weak rationale, no safety factor justification |
| Safety | Safety pharmacology, immunogenicity, stopping rules | Missing cardio/CNS panels, no clear pause criteria |
The nonclinical package should show that the proposed clinical dose and schedule are supported by primary pharmacology, pharmacokinetics, and IND-enabling toxicology in a relevant species. Gaps here are a frequent source of FDA information requests and can contribute to clinical hold risk.
CMC review looks at drug substance and drug product characterization, analytical methods, stability, and manufacturing controls. Even early-phase INDs benefit from clearly defined release specifications and a justified impurity strategy.
Protocols are reviewed for design coherence: endpoints aligned to mechanism, eligibility criteria that match the safety profile, dose escalation rules, and a monitoring plan appropriate to the anticipated risks.
Starting-dose rationale should translate the most sensitive nonclinical finding into a human equivalent dose with an explicit safety factor, or use a MABEL approach where the mechanism warrants it.
A coherent safety story typically includes cardiovascular, respiratory, and CNS assessments, plus stopping and pause rules that line up with the highest-likelihood adverse events.
An IND readiness checklist is a structured set of review items across nonclinical, CMC, clinical protocol, starting-dose, and safety dimensions used to identify gaps and FDA question areas before an Investigational New Drug application is submitted.
It is typically used in the months leading up to a planned IND submission, after pivotal nonclinical studies are underway and a draft clinical protocol exists, so that gaps can still be addressed before the submission window closes.
Regulatory affairs leads, translational scientists, CMC leads, and clinical development leads typically review the checklist together. External regulatory consultants and AI-assisted readiness workflows may support the review.
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