Tuesday, September 2, 2014

Position at FDA in Environmental Assessment of Pharmaceuticals

Hiedi Bethel forwarded the following information to me about an interesting position opening at the FDA.  Please follow the link below if interested in more information. 

A research fellowship opportunity recently opened here at the Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA).  Please distribute.

The candidate should have or be pursuing a doctoral degree in aquatic ecology, biology, biochemistry, toxicology or a closely related field, with education and/or experience primarily with low-dose chemical-induced (preferably from pharmaceuticals) perturbations of the endocrine systems of aquatic vertebrates.  Other useful qualifications include education and/or experience with other adverse endpoints, including stressor additivity/synergism and antimicrobial resistance; testing assays and strategies currently established at or undergoing development by other FDA Centers, agencies, and countries/regions; and the regulatory science framework regarding environmental assessments at CDER and other FDA Centers, agencies, and countries/regions.

As background, the National Environmental Policy Act of 1969 (NEPA) requires all Federal agencies to assess the environmental impacts 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.  Some drugs with hormonal activity have been shown to affect the environment, and thus FDA is examining whether additional ecotoxicity testing should be required for applications submitted for drugs with hormonal activity. In addition, antimicrobial, additivity/synergism, and other properties have been implicated for possible adverse environmental and human effects.

See http://orise.orau.gov/fda/applicants/description.aspx?JobId=17033 for more details.

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