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FDA Combination Product Submissions May Need More Drug Info

 
• By Elizabeth Orr

Recent guidance document revisions mandate that combination product sponsors provide additional information on the patent and exclusivity status of any drug components. The US agency addressed the changes in a March 20 webinar.

Combination product applications submitted after April 2 may be rejected if they don't explain the patent and exclusivity status of any drug components, FDA staff said during a March 20 webinar.

The requirements arise from recent updates that align two guidance documents with a provision in 2016's 21st Century Cures Act...

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