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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 a designation-decision appeal "under consideration" for 18 months and counting.

A new citizen petition says US FDA's Office of Combination Products (OCP) should establish timelines for appeals of designation decisions, citing "significant delays" in FDA reviews and in responses to challenges by companies to designations of products deemed to have a drug or biological primary mode of action.

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

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