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Literature reports the uncertainty level of these equations of state for monitoring the 2-propanol/hydrogen 39 , furfuryl alcohol/hydrogen 22 , and allyl alcohol/hydrogen 40 phase equilibria
And so FDA is going to need to use a different lens. Unlike FDA approval of a new drug, which requires years of clinical trials demonstrating safety and effectiveness, placement on the 503A Bulks List answers a different regulatory question
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