FDA roundtable spotlights small‑manufacturer struggles with PMTA evidence needs Small ENDS manufacturers urged the FDA Center for Tobacco Products to give clearer, more predictable standards for PMTA submissions while agency scientists described existing technical expectations and urged pre‑submission engagement; toxicology, pharmacology, manufacturing consistency and adult‑benefit evidence emerged as the main hurdles.

Small manufacturers are calling on the FDA for clearer, more predictable standards to navigate the complex landscape of premarket tobacco product applications.

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