Cleaning Up The ‘Orange Book’: US FDA Clarifies Market Status Reporting Requirements

04 Feb 2019

Draft guidance addresses sponsors’ obligations to notify agency about drugs withdrawn from sale or not available for sale within 180 days of approval; FDA has reviewed ‘substantial portion’ of more than 10,000 one-time marketing reports that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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The US FDA’s “Orange Book” modernization plan includes measures to ensure the compendium accurately reflects the current marketing status of approved products.

Toward that end, FDA released a draft guidance Jan. 30 intended to help new drug application (NDA) and abbreviated...