Combination Products Coalition (CPC)

News

Op Ed: Counting Our Blessings with the Office of Combination Products
Why the OCP might still be the best thing that has ever happened to industry.

As reported in Seriously, What is Going On at the Office of Combination Products?, some in the medical device community have criticized the Office of Combination Products (OCP) at FDA. In particular, those critics have accused OCP, ironically, both of being weak because the office lacks independent authority and for overstepping its bounds. How is that even possible?

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CGMPs for Combination Products–Final Rule and Implementation: An Interactive Analysis with Industry and FDA
In the wake of the U.S. Food and Drug Administration (FDA) issuing the final rule on current Good Manufacturing Practices (CGMPs) for combination products, the Combination Products Coalition (CPC), in collaboration with the Regulatory Affairs Professionals Society (RAPS), will be hosting an interactive session examining the contents of the final rule and the agency’s implementation plan.

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Combination Products Coalition pleased with FDA publishings
The Combination Products Coalition is pleased to see the FDA guidance published on when submissions would be required for postapproval modifications to a combination product. Although we will continue to review individually and as a coalition our initial assessment is that it would increase the number of filings pretty radically by declaring that low risk device constituent parts are all of a sudden to be viewed through the PMA lens.

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