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Interview: Putting The Pieces Together For Combo Products Oversight

 
• By David Filmore

Bradley Thompson has been shepherding the Combination Products Coalition for more than a decade. He says the recent spotlight from FDA and other policymakers put on the combo-products space, including in a recent user-fee deal, is a welcome development after a period of neglect. Thompson spoke to Medtech Insight about the numerous reforms in the works and the state of the sector.

Puzzle

An eight-point plan recently hashed out between US FDA and the drug industry should go a long way to putting oversight of device-drug and device-biologic combination products on a more predictable path, says Bradley Thompson, the point person for a coalition representing combination-product industry interests.

The plan was included in the Prescription Drug User Fee Act reauthorization (PDUFA VI) commitment letter agreed to by the agency and key pharmaceutical industry trade groups this...

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