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Environmental assessment exemptions will be granted to some NDA applicants.

This article was originally published in The Tan Sheet

Executive Summary

FDA TO EXEMPT FROM ENVIRONMENTAL ASSESSMENTS drug applications that would lead to very little or no increased use of an active moiety, according to a proposed rule published in the April 3 Federal Register. The proposal would exempt drug applications that may result in an increase in use of an active moiety at a concentration in the environment of less than one part per billion.
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