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Environmental Activites at FDA's Center for Drug Evaluation and Research

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Abstract:

The Food and Drug Administration (FDA) is the primary Federal agency responsible for the regulation of pharmaceuticals and personal care products in the United States. The agency's primary role is the assessment of applications for clinical investigations and the marketing of drugs and devices for human and animal use. The FDA Center for Drug Evaluation and Research (CDER) regulates the safety and efficacy of pharmaceuticals for human use. Drug companies must submit extensive information to CDER regarding the safety of a drug. In addition, the FDA is required under provisions of the National Environmental Policy Act (NEPA) to consider the environmental impacts of approving drug and biologics applications as an integral part of its regulatory process. FDA's regulations at 21 CFR part 25 specify that environmental assessments (EAs) must be submitted as part of certain new drug applications (NDAs), and for various other actions, unless the action qualifies for categorical exclusion. CDER environmental activities also extend to working closely with sister agencies on the development of Federal guidelines for drug disposal, an interagency research strategy to define and prioritize research and data needs and towards gaining a better understanding of the ecological and human health implications of pharmaceutical residues in water as a consequence of drug use and disposal.

Document Type: Research Article

DOI: https://doi.org/10.2175/193864708788809527

Publication date: 2008-01-01

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