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Description

It requires a complete review of clinical data, toxicology data, manufacturing processes, finished product formulations, therapeutic indications, and administration routes

Medicine 98 (15), e15180

& Vinters, H

Innate immunogenicity and in vitro protective potential of Schistosoma mansoni lung schistosomula excretory-secretory candidate vaccine antigens

The critical caveat: the formal FDA reclassification has been announced but not yet published in the Federal Register as of mid-March 2026

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