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At FDA, one of our foremost responsibilities is to evaluate
and if medical products meet the appropriate standard, to approve or clear
drugs, biological products and medical devices. We know that these products are
safer and more effective for everyone when they are tested in clinical trials
that include diverse populations. The design and analysis of clinical trials
has evolved significantly over the last three decades. FDA now has a variety of statutory,
regulatory, and policy-related tools at its disposal that provide a framework
for guiding medical product sponsors and FDA review teams in the collection,
subset analyses, and communication of these data. Read
more.
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