2017 Complete Response Letters: Fewer Than 2016, Still More Than Years Past
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.
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Complete Response Letters: Firms See Value In Public Release, Don't Expect It Will Happen
One industry CEO says it would on net be beneficial even though some companies would suffer if they were made public.
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.
Q&A With US FDA Commissioner Scott Gottlieb
US FDA Commissioner Scott Gottlieb sat down with the Pink Sheet and Medtech Insight reporters for an exclusive chat about his ongoing regulatory work and plans for the future.