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There is little difference in the FDA approved labels of the drugs, and neither have on this occasion gained approval for patients who are new to injectable therapy. Sanofi may have most to lose ...
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After years of legal wrangling, graphic warning labels will be placed on cigarette ... that manufacturers submit a plan and obtain FDA approval “for the random and equal display and distribution ...
Source: CRA Analysis In England, two key mechanisms were often used to achieve approval: label restrictions or a patient access scheme (PAS). Over one third (37%) of orphan drugs appraised by NICE ...