Environmental Assessments for Traditional Tobacco Products
Scope / Challenge
- Develop environmental assessments for traditional tobacco products when no official guidance or requirements were available from the FDA Center for Tobacco Products (CTP). These environmental assessments were critical to the client’s goals of obtaining authorization from the FDA to place new or modified products on the U.S. market.
Solution & Services
- Our team developed an FDA Environmental Assessment program that included a process and procedures to develop environmental assessments and a framework to create the environmental assessments.
- We developed certain environmental assessment methodologies for different types of tobacco products. This included various types of quantitative (exposure modeling or analysis) and qualitative evaluations.
- We provided guidance and support to the client on responding to official questions from the FDA on Environmental Assessments during the agency’s Substantive Review process.
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