Enforcement for 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 regenerative medicine, promise the possibility to treat and perhaps cure various medical conditions.

The Center for Biologics Evaluation and Research stated that companies should not commercialize 351 products after May 31, 2021, under an NDA. These products include biological products such as a “virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, … applicable to the prevention, treatment, or cure of a disease or condition of human beings”. As a result companies such as Organogenesis Holdings will be removing their Renu (contact lens cleaner) and NuCel (a cryopreserved amniotic suspension allograft) products from the market.

The FDA is clearly stating these 351 products shouldn’t be sold as of June 1 2020. Going forward human cells, tissues, or cellular or tissue-based products (HCT/Ps) will be under heavy scrutiny for compliance with FDA 361 regulations as well. To avoid the costs associated with obtaining FDA approval many companies will continue to remove these products. Because many of these products are over-the-counter medications many frequent users of these medications will have to find alternatives, which may lead to higher prescription costs for patients as they lose access to these medications.

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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