Abstract
This article provides an overview of a presentation of the environmental assessment process for drugs in the United States from the joint DIA/HESI/SAPS conference on Environmental Assessment of Human Medicines held in Stockholm, Sweden, May 22–23, 2006.
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References
Food, Drug, and Cosmetic Act of 1938.
Public Health Service Act of 1944.
National Environmental Policy Act of 1969.
Code of Federal Regulations, Title 21 Part 25, Title 40 Part 1500–1508.
Food and Drug Administration. Guidance for Environmental Assessment of Human Drug and Biologics Applications. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER); July 1998. Available at: http://www.fda.gov/cder/guidance/1730fnl.pdf. Accessed October 21, 2006.
US Endangered Species Act of 1973.
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Webber, K., Spindler, P. Environmental Assessment of Human Pharmaceuticals in the United States of America. Ther Innov Regul Sci 41, 155–157 (2007). https://doi.org/10.1177/009286150704100205
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DOI: https://doi.org/10.1177/009286150704100205