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

 
• By Sue Sutter

Draft guidance addresses sponsors’ obligations to notify agency about drugs withdrawn from sale or not available for sale within 180 days of approval; FDA has reviewed ‘substantial portion’ of more than 10,000 one-time marketing reports that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

White pills on an orange background. - Image

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Toward that end, FDA released a draft guidance Jan

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The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.

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Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
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