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Outlook For Orange Book Update Not Too Rosy

Executive Summary

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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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Draft guidance addresses sponsors’ obligations to notify agency about drugs withdrawn from sale or not available for sale within 180 days of approval; FDA has reviewed ‘substantial portion’ of more than 10,000 one-time marketing reports that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.

US FDA Continues Reviewing Marketing Reports, Will It Punish Scofflaws?

Six months after submission deadline, about one-third of one-time marketing status reports have been reviewed, agency says.

US FDA Continues Reviewing Marketing Reports, Will It Punish Scofflaws?

Six months after submission deadline, about one-third of one-time marketing status reports have been reviewed, agency says.

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