What type of specific research programs might be structured by regulatory strategy roles to answer a question posed by the FDA?

Answer

Fit-for-purpose studies

Individuals focusing on regulatory RWE strategy often structure entire research programs, known as fit-for-purpose studies, specifically to address a precise question or requirement posed by governing bodies like the US Food and Drug Administration (FDA).

What type of specific research programs might be structured by regulatory strategy roles to answer a question posed by the FDA?
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