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With FDA Guidance Urging Innovation, Will Novel Smoking Cessation Products Surface In US?

Executive Summary

CDER reiterates expectation for multiple trials to demonstrate efficacy for an IND different from approved products, such as route of administration, for smoking cessation or reduction in risk of relapse. Agency offers access to expedited approval pathways by showing significant improvement in efficacy or safety over existing therapies or addressing unmet medical need.

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