Comment from Optisources Inc

Docket No. FDA-2026-N-4699 — Expedited IND Pilot Program; Request for Information Optisources, Inc. (McLean, Virginia; CAGE 6AKU4; UEI NQF1CFXHGWX5) comments on the technology, data-integrity, confidentiality, and evaluation-infrastructure dimensions of the pilot and on equitable participation by smaller organizations. Optisources does not sponsor drug development and does not seek QRI status. The pilot's credibility rests on two things the notice relies on: the timing of the rolling submission, which starts the 30-day clock, and the evaluation data used to judge success, which QRIs and sponsors with an interest in the result would report in part. Optisources recommends the platform incorporate tamper-evident provenance, so each rolling component, QRI recommendation, and FDA feedback event is independently verifiable as to content, authorship, timing, and sequence, and that timing data be captured automatically instead of self-reported. Rolling review also presumes FDA can act on each component as it arrives. That holds only if the platform ingests distributed, heterogeneous submissions into one queryable corpus, reconciles QRI vocabularies through a governed semantic layer built on standards FDA already uses, and applies AI-assisted classification, with criteria authored by FDA reviewers, to surface completeness signals. Absent this, rolling review reverts to batch review under a new name. On equity, Optisources recommends FDA consider providing or certifying a common submission platform so platform capability is not itself a barrier to a diverse QRI pool.