FDA Exploring Whether Public Shaming Can Stop REMS Abuses
Commissioner Gottlieb says agency is considering publicizing letters it has written to brand companies indicating it would not violate a REMS to sell a generic company samples for testing.
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US FDA cut first-cycle review time 46% between fiscal year 2013 and FY 2015, but more than 900 ANDAs still awaited review by end of 2016.
Prioritizing ANDAs entering markets with fewer than three approved generics not expected to become a major advantage until first-cycle clearances increase.
Gottlieb favors making the letters detailing application problems public, but industry still may oppose it; Senate schedules cloture vote for confirmation.