Chapter 5 90 Figure 3: Venn-diagram of approvals where the FDA and or the EMA relied on data from expanded access programs to form the clinical efficacy profile. The level of evidence associated with these data by either regulators could be pivotal or supportive. Figure 4: Bar chart of dates of marketing authorization of 25 FDA and 24 EMA approvals that relied on realworld data from expanded access for the clinical efficacy profile.
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