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If, at any time, FDA determines that any of the grounds for withdrawal in section 911(j) apply, including a determination that the applicant, based on new information, can no longer make the demonstrations required under section 911(g) for a modified risk order, FDA is required to withdraw the order

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Another Japanese pooled analysis revealed an increased doseresponse relationship between alcohol and colorectal cancer incidence, and the relation was more apparent in Japanese than in Western populations 33

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10.1046/j.1365-2796.1996.16844000.x Norregaard J, Jorgensen S, Mikkelsen KL, Tonnesen P, Iversen E, Sorensen T, Soeberg B, Jakobsen HB: The effect of ephedrine plus caffeine on smoking cessation and postcessation weight gain