Cleaning Up The ‘Orange Book’: US FDA Clarifies Market Status Reporting Requirements
Draft guidance addresses sponsors’ obligations to notify agency about drugs withdrawn from sale or not available for sale within 180 days of approval; FDA has reviewed ‘substantial portion’ of more than 10,000 one-time marketing reports that were due in February 2018.
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US FDA plans new guidances on real-world data, clinical trial statistics, and patient input in coming this year.
With about 20,000 products eligible for US marketing status report on drugs in Orange Book, there is no timeline for all changes to be made.
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