Information for Practitioners-
FDA’s Regulatory Oversight of Regenerative Medicine Products Webinar
The FDA’s Center for Biologics Evaluation and Research (CBER) is hosting a public webinar on November 17, 2022, at 11:00 am.
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 will explain the regulation of regenerative medicine products and its concerns about the proliferation of unapproved and potentially harmful products.
Meeting Information and Registration
This event is free and open to the public. However, registration is required. Please see the link below to register.
- Date: Thursday, November 17, 2022
- Time: 11:00am to 12:30pm
- Location: The webinar will be held via Zoom.
There will be an opportunity during registration to share a question with the speakers and panellists.
Register for the webinar here.