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rather, FDA was seeking a thoughtful engagement and discussion.[8] How FDA viewed the discussion is summed up in the following sentence: In general, TPSAC felt that the applicants study was reasonable and its proposed modified risk claim seems to convey an accurate message.[9] The TPSAC meeting is also cited in a sub-section on the importance of the epidemiological literature based on Swedish and Norwegian studies and the connection to the Swedish Match internal quality program GOTHIATEK

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