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Occupational Health & Safety

The new release is the first of two draft guidance document supporting the development of novel inhaled nicotine replacement therapies that could be submitted to the FDA for approval as new drugs. The guidance, "Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products," focuses on data recommended to evaluate potential toxicities associated with orally inhaled nicotine-containing drug products, including products such as e-cigarettes that are intended for smoking cessation and other long-term uses that would make them subject to regulation as drugs.