How the IND 30-day Hold Impacts Clinical Trial Activities
Advarra
SEPTEMBER 23, 2022
Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain. . The Food and Drug Administration (FDA) is the federal entity in the U.S. charged with (among other things) “ensur[ing] that safe and effective drugs are available to improve the health of the people in the United States.” .
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