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When to request INTERACT, pre‑IND and pre‑BLA meetings, and related timelines
Summary
OTP panelists advised sponsors to request INTERACT meetings early (after proof of concept, before definitive tox), to seek pre‑IND when preparing IND-enabling studies, and to request pre‑BLA at least four months before planned BLA submission; rolling review is limited to products with breakthrough, RMAT, or fast track designations.
Mara Miller (director, Division of Review Management and Regulatory Review 2) said INTERACT meetings are appropriate when a sponsor has identified an investigational product and preliminary proof-of-concept but has not yet completed definitive toxicology studies. "So interact meetings should be requested early in product development," she said, adding denials are common when a prior INTERACT meeting occurred for the product, the package is missing or deficient, or the development stage is inappropriate.
Jessica Behmer and Beatrice Colangal provided timing guidance for later milestones: request a pre-BLA meeting at least four months before planned submission and schedule it to be held no more than two months before submission; Beatrice noted rolling review is reserved for products with breakthrough, RMAT, or fast track designations and that formal rolling-review requests are processed after a pre-BLA meeting.
