vol1 - Page 311

 that directly relate to medical use and safety under medical
 supervision, w7_/ o
 In its brief, DEA goes one step further -_ expanding
 upon the #safety and efficacy # requirements of the NDA procedure_
 by requiring inflated efficacy and safety demonstrations.
 ---iDEA expands the efficacy requirement, rejected by the
 FirstCircuit, in two ways° First, the Agency appears to requi__
 that marijuana not only be effective, but that it also be the
 ...... most effective drug for each indication discussed in this case°
 Second, the Agency appears to state that the only means of
 showing efficacy is through the use of double-blindt randomized
 studies. This interpretation is unquestionably invalid and wou3




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