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Combination Product Designations At US FDA Need Faster Appeals, Petition Says

 
• By Michael Cipriano

No sponsor is named in the citizen petition, but it was filed on behalf of an applicant that has had an appeal of a designation decision 'under consideration' for 18 months and counting.

FDA entrance sign 2016

A new citizen petition is aiming to push the US FDA's Office of Combination Products (OCP) to establish timelines for appeals of designation decisions, citing "significant delays" in reviews and in challenges to designations of products with a drug or biological primary mode of action.

The petition dated March 3 does not name a sponsor, but was filed on behalf of a client...

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