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SILEx MAY 2023: Recent Challenges in FDA Categorical Exclusion and Environmental Assessments of Human Pharmaceuticals
An Vanwormhoudt, MSc, presenting Recent Challenges in Food and Drug Administration (FDA) Categorical Exclusion (Cat Ex) and Environmental Assessments (EA) of Human Pharmaceuticals.
- Short introduction of what an environmental assessment/categorical exclusion is and when it is needed
- Recent questions/feedback from FDA to Cat Ex and EA’s and consequences
Intended audience Veterinary staff members and Study Directors