FDA Enforcement of Regenerative Medicine Products

April 28, 2021

The FDA has recently confirmed definitive enforcement of its regulations regarding regenerative medicine products. Effective May 31, “discretionary” compliance by manufacturers, distributors, and their clinical customers will no longer be allowed. As a result, they can expect increased scrutiny and heightened risk of public enforcement letters and penalties. Moreover, these risks are amplified by the increased focus of state authorities, and indeed concerns expressed by patients themselves, in this area.

All this underscores the importance of independent and verifiable real-world evidence, relevant documentation, and transparent, accurate communications to HCP’s and patients. This is precisely the purpose of Circles. They create and maintain -- in a cost-efficient and minimally burdensome manner – evidence-based engagement with HCP and patient communities. Those communities in turn generate critical real-world data and transparency.

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