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The value of a pre-IND interaction depends on answerable scientific questions. The sponsor’s proposed approach, supporting rationale and the development decision that FDA feedback could change should be understandable without relying on a long presentation or unexplained attachments.
Identify the decision needed
Interpret meeting procedures for the product and reviewing office. The OTP pre-IND page concerns cellular and gene therapy products; its operational instructions should not automatically be applied to all medicines. Confirm the current meeting type and office-specific instructions at the outset.
Build the question package
For each question, state the proposed approach, a concise supporting data summary and an alternative. Identify dependencies between CMC, toxicology and the clinical plan. Replace broad requests to approve a programme with a defined decision about dose support or a specific study design feature.
Rehearse the evidence
Make the clinical material and toxicology support visible in the question set. An internal rehearsal can reveal questions the existing evidence cannot support. Maintain a version list connecting the meeting request, briefing package and any subsequent clarifications so reviewers know which proposal was discussed.
- Prioritize questions by their development decision impact.
- Attach a sponsor position and evidence to each question.
- Transfer minute-based actions to the development plan.
Translate feedback into a plan
Convert meeting minutes into an action table: feedback, sponsor interpretation, evidence needed and owner. Do not describe scientific advice as regulatory permission. Reassess when new information changes an assumption and connect the interaction’s output to actual decisions in IND preparation.
Frequently asked questions
- Is a pre-IND discussion approval of an IND?
- No. Scientific feedback and the subsequent IND process are different steps.
- Do OTP timelines apply to every medicine?
- No. Verify the product class, reviewing office and current meeting instructions.