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US FDA’s ‘Active Moiety’ Approach On NCE Exclusivity Codified Under Drug Pricing Legislation

Executive Summary

Measure clarifies the meaning of new chemical entity by replacing the term ‘active ingredient,’ which encompasses esters and salts, with ‘active moiety’ as defined by the FDA; legal experts are skeptical the measure will generate cost savings and say it gives the agency wide latitude to make future changes in eligibility for 5-year exclusivity.

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