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Judith Meritz, J.D.

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Navigating Drug-Device Combination Product Approval

Posted by Judith Meritz, J.D. on 11/3/16 11:11 AM


The popularity of drug-device combination products has been soaring. These products — which comprise combinations of drugs, biologics and devices — had sales reaching $22 billion in 2014, and the market is expected to grow to $31 billion by 2019.1

However, growth in this sector is threatened by a lack of alignment within the FDA, which is slow to approve drug-device combination products.  For those considering developing a combination product, I thought it helpful to provide an FDA primer to help people navigate the approval process and understand where the challenges are.    

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Topics: Medical Device, FDA, Combination Products