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Clinical Infectious Diseases
New clinical infectious diseases research from A. Sutton et al outlined
April 1st, 2008
"Marketing approval of biological products by the US Food and Drug Administration must comply with requirements of Code of Federal Regulations title 21 part 25, ''Environmental Impact Considerations.'' An environmental impact statement is usually not required. Environmental assessment is required unless excluded," researchers in the United States report. "As naturally occurring substances, biological products qualify for categorical exclusion if manufacture and use do not significantly alter their concentration or distribution in the human environment. The manufacturing process and establishment descriptions in the license application should include enough detail to...
Source: TB & Outbreaks Week (2008-04-01)
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