A fellowship opportunity is currently available in the Office of New Drug Quality Assessment within Office of Pharmaceutical Science (OPS) at the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA).
The National Environmental Policy Act of 1969 (NEPA) requires all Federal agencies to assess the environmental impact of their actions. To comply, FDA implements 21 Code of Federal Regulations (CFR) Part 25, which includes a requirement for an environmental assessment (EA) if "extraordinary circumstances" indicate that the specific proposed action may significantly affect the quality of the human environment. Recent research indicates that some drugs with hormonal activity in the environment may exhibit such circumstances, and FDA may need to require additional ecotoxicity testing for applications submitted for drugs with hormonal activity. In addition, antimicrobial, additivity/synergism and other properties have been implicated for possible adverse environmental effects, as well as human effects through environmental pathways. The selected participant will join EA staff in identifying ecological toxicity endpoints, study designs and testing approaches for drugs with hormonal activity in the environment; assessing other properties, including antimicrobial resistance and additivity/synergism; evaluating approaches by other Centers, agencies and countries/regions; and determining how to best use the results within CDER's current regulatory structure. See http://orise.orau.gov/fda/applicants/description.aspx?JobId=17033 for more details. James P. Laurenson Senior Toxicologist/Environmental Officer Office of Pharmaceutical Science Center for Drug Evaluation & Research U.S. Food & Drug Administration 10903 New Hampshire Ave., Bldg. 21, Rm. 1626 Silver Spring, MD 20993 301-796-4872 (office) 703-342-9496 (cell) [email protected]<mailto:[email protected]>
