Gottlieb Promises More Balance On Combination Product Reviews

US FDA Commissioner Scott Gottlieb told a Medical Device Manufacturers Association crowd that he will try to assure more balance between device and drug regulatory leads for combination product reviews at the agency.

US FDA is working hard to create a more efficient consultation process between different regulatory centers, but also one that is fair for all sponsors of combination products, whether for combination device and drug, device and biologic, or drug and biologic products, Scott Gottlieb said May 3.

But device manufacturers continue to perceive that it is the drug center at FDA, rather than the device center, that...

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