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In Brief: Environmental assessments

Executive Summary

Environmental assessments: Categorical exclusions will be granted for drug applications that do not result in increase of active moiety use or in increases at a concentration in the environment of less than one part per billion, according to FDA's proposed rule to amend its regulations under the National Environmental Policy Act of 1969. The changes published in the April 3 Federal Register implement the Clinton Administration's Reinventing Drug and Medical Device Regulations initiative announced in April 1995 ("The Pink Sheet" April 10, 1995, p. 9). Also covered by the exclusions are INDs, antibiotic and insulin batch testing, and lot release testing for biologics. Environmental assessments still will be required for products that pose "serious harm" to the environment or that "adversely affect" a habitat or species covered by the Endangered Species Act...

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