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However, more than 150 pages of regulatory documents reviewed by the Chronicle indicate the company has struggled to meet the FDAs expectations since the federal agency ramped up compounding pharmacy enforcement efforts in 2013

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Demonstrated Safety and Tolerability Profile 1 With RADICAVA , the most common adverse reactions were contusion, gait disturbance, and headache 1, a (see footnote) Safety profile was demonstrated in pooled placebo-controlled trials b (see footnote) in which 184 patients with ALS were administered RADICAVA (edaravone) (60 mg) in 24-week treatment cycles

Regularly monitor the number of settled bacteria and suspended particles