Information for Practitioners - FDA’s Regulatory Oversight of Regenerative Medicine Products
November 17, 2022
- November 17, 2022
- 11:00 AM - 12:30 PM ET
The FDA’s Center for Biologics Evaluation and Research (CBER) hosted a public webinar on November 17, 2022.
CBER regulates regenerative medicine products, including human cells, tissues, and cellular and tissue-based products (HCT/Ps), intended to treat or cure diseases or medical conditions. These products generally require FDA approval to be distributed or marketed to consumers. Before approval, these products require FDA oversight in a clinical trial.
Manufacturers, suppliers, distributors, and healthcare providers continue to broadly market unapproved regenerative medicine therapies to patients. These products have risks but are often illegally marketed as being safe and effective for the treatment of a wide range of diseases or conditions, even though they haven’t been adequately studied to demonstrate the claims of safety and effectiveness.
In this webinar, CBER subject matter experts explained the regulation of regenerative medicine products and its concerns about the proliferation of unapproved and potentially harmful products.
View the webinar recording for Information for Practitioners - FDA’s Regulatory Oversight of Regenerative Medicine Products.
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|Meeting Transcript - Information for Practitioners - FDA’s Regulatory Oversight of Regenerative Medicine Products||pdf (269.62 KB)|