FDA Contradicts AAM's Generic Market Consolidation Argument
As the generic industry trade group warns shortages could emerge as number of manufacturers contracts, US FDA says many new firms gaining approvals and identifying facilities.
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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.
FTC Acting Chairman Ohlhausen predicts agency will continue to focus on competition issues involving barriers to generics but says 'we need to learn more about how these markets are working today.'
In a year defined by application surges, more than 200 ANDAs were submitted in September, the last month of fiscal year 2017, likely to avoid paying a much higher application fee instituted Oct. 1.