4 Key Takeaways For Combination Products As We Move Into 2023

The world of combination products has been evolving ever since the FDA final rule on cGMP practice requirements for combination products was issued on Jan. 22, 2013. It was followed by the FDA’s final companion guidance on the same subject that was released in January 2017. As the use of combination products in industry and around the globe continues to grow, corresponding challenges in this space also grow.

To stay abreast of this dynamic segment of the industry and its associated regulatory expectations, meetings such as the AFDO/RAPS Combination Product Summit have been held. (AFDO is the Association of Food and Drug Officials, and RAPS is the Regulatory Affairs Professionals Society.) Historically, this meeting had been coordinated by Xavier Health. This year, for the first time, the AFDO/RAPS Healthcare Products Collaborative coordinated the summit, and it was again co-sponsored by the FDA. The planning of this meeting involves industry leaders along with representatives of the FDA’s Office of Combination Products (OCP). I delve into the summit’s four key takeaways below.

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