What Goes Up … US FDA Expects 2016 NME Approval Total To Come Down
After a record-setting 2015 for new drug approvals, there were not enough applications with user fee goals in 2016 to reach that level again.
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Keeping Track: US FDA Greenlights Two More Novel Drugs, But Smacks Down Golodirsen
The latest drug development news and highlights from our US FDA Performance Tracker.
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.
Gottlieb Q&A: Confirmation Is Nearing, Will Complete Response Letters Finally Get Released?
Gottlieb favors making the letters detailing application problems public, but industry still may oppose it; Senate schedules cloture vote for confirmation.