Advancing the Development of Safe and Effective Regenerative Medicine Products

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The FDA regulates and oversees the evolving science that brings new therapies to patients. Cell-based treatments, which include stem cell therapies, promise the possibility to treat and perhaps cure various medical conditions.

The agency created a framework in November 2017 to support careful development of regenerative medicines. Regenerative Medicine Advanced Therapy (RMAT) is an example of an expedited program that helps innovative treatment reach patients where no other option might be possible. The FDA have communicated to clinics, manufacturers, and others in the industry about their compliance and enforcement policy and how a new timeline will occur May 31, 2021.

The FDA created programs that invite HCT/P manufacturers to participate with the agency, for example, the Tissue Reference Group (TRG) Rapid Inquiry Program (TRIP). TRIP supported HCT/Ps providers to receive a concise non-binding FDA evaluation on specific HCT/Ps guidelines. TRIP was meant to be temporary. TRIP started June 2019 and concluded on March 31, 2021.

Unfortunately, we continue to see advertising of unapproved treatments for various medical conditions. Many treatments appear to be HCT/Ps that are subject to agency approvals in order to be considered medications, devices and/or biological products for clinicians to treat patients.

It is important for people to know the risks and dangers of these promoted therapies and distinguish them from treatments that have been studied in clinical trials and evaluated by the FDA. The agency has made it clear that manufacturers, clinics, or health care practitioners cannot endanger patients nor violate the law.

They have taken measures against unscrupulous actors, which entails several warning letters, as well as enforcement for serious violations of the law. We have seen a clinic close recently as a consequence. The FDA urges the public to ask many questions from health care providers before seeking these treatments. It is crucial people seek legally marketed products, that have been studied in clinical trials under FDA regulations.

The FDA reaffirms its ambition to support safe and effective regenerative medicine treatments, including stem cell-based therapies, to help patients with medical needs. They look forward to collaborating with stakeholders sharing this goal. Indeed, we, as a patient-centric organization, share this goal as well.

The above is our summary of a message from Dr. Peter Marks, the Director of the Center for Biologics Evaluation and Research. You can find the original text on the FDA website.

Our Editorial Note: Contact us if you would like to learn more about regenerative medicine and how it may help patients with Covid-19 and other medical conditions.


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