Environmental Assessments for Premarket Tobacco Product Applications (PMTAs)
Scope / Challenge
- Develop environmental assessments for new tobacco products, through the FDA’s PMTA process, which were not on the U.S. market. The non-U.S. client wanted to obtain authorization to bring the novel tobacco products to the U.S. market and be first-to-market products. The client was a non-U.S. business with no real experience with the FDA environmental assessment process. Also, the FDA had limited guidance and requirements for environmental assessments for tobacco products.
Solution & Services
- With limited guidance from the FDA, our team provided guidance and support to the client to understand the U.S. environmental assessment process and requirements.
- We developed a framework to create the environmental assessments and worked with the client to obtain the necessary information and data to develop the environmental assessments.
- We developed multiple environmental assessments that were successfully processed through the FDA and received Findings of No Significant Impact (FONSIs).
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