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The US Food and Drug Administration (FDA) negotiates the evidence necessary for drug approval with pharmaceutical sponsors. The resulting data package submitted in support of approval includes labeling that conveys… Click to show full abstract
The US Food and Drug Administration (FDA) negotiates the evidence necessary for drug approval with pharmaceutical sponsors. The resulting data package submitted in support of approval includes labeling that conveys the benefits and risks of a particular agent. Recent approvals in hematology
Keywords:
flexibility innovation;
innovation fda;
novel regulatory;
fda novel;
fda;
approval
Journal Title: Blood
Year Published: 2017
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Journal Title: Blood
Year Published: 2017
Link to full text (if available)
Share on Social Media: Sign Up to like & get
recommendations!