Deleted Tweet from Scott Gottlieb, R-D.C.
Deleted Tweet from Scott Gottlieb, M.D.
SteveFDA (R-D.C.)
@SGottliebFDA
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For serious conditions with small patient populations (rare diseases) a single trial may be accepted to show safety and efficacy, demonstrating clinical benefit. This has helped result in approvals where there were previously no satisfactory approved drug
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