Public Complete Response Letters? Don’t Hold Your Breath
In interview with the Pink Sheet, US FDA Commissioner Gottlieb indicates agency won’t be making complete response letters public any time soon. Agency will still strive for greater transparency in its regulatory decisions, however.
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US FDA's complete response letters dropped from 41 in 2016 to 30 in 2017; quality issues as share of total letters continued to climb.
One industry CEO says it would on net be beneficial even though some companies would suffer if they were made public.
Why not wait for the confirmatory trial to read out before approval, at least in the context of an especially uncertain or controversial surrogate marker?