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An FDA approval is a separate process that requires rigorous clinical testing and a regulatory review

Major Reclassification : This detailed, stepwise procedure applies to applications that break new ground, such as a new type of medicine or condition being considered for a classification change

Complete concentration and dosing reference chart This table shows exactly what happens at each reconstitution ratio

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For each eligible study, two authors (MM and AN) independently extracted data, which was then reviewed by a third author (JV) using a piloted spreadsheet, in accordance with Cochrane Collaboration guidelines (Higgins and Green, 2008)