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Breaking: FDA Announces Program to Help Manufacturers of HCT/Ps Understand Regulatory Pathways for Specific Products

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The U.S. Food and Drug Administration is announcing a temporary program called the Tissue Reference Group (TRG) Rapid Inquiry Program (TRIP), which will operate as part of FDA’s Tissue Reference Group.

The program will assist manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/Ps), including those stakeholders that market HCT/Ps to healthcare professionals and/or patients, obtain a rapid, preliminary, informal, non-binding assessment from the FDA regarding how specific HCT/Ps are regulated.

The agency intends to respond to inquiries that contain sufficient detail for evaluation within three days of receipt, as resources permit. The program will be available until December 31, 2019.

View full FDA announcement:

https://www.fda.gov/news-events/fda-brief/fda-brief-fda-announces-temporary-streamlined-program-help-manufacturers-human-cell-tissue-and

Source: U.S. FDA

FDA advances new efforts to promote development of safe and effective regenerative medicine products

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SILVER SPRING, Md., Feb. 15, 2019 — “We’re at an inflection point when it comes to cell and gene therapies. These treatments have the potential to address hundreds of vexing human diseases and conditions. When we first issued our comprehensive regenerative medicine policy framework in November 2017, our goal was to achieve a balanced and risk-based approach to support product development in cell-based therapies, while clarifying the FDA’s authorities and enforcement priorities to make sure we were protecting patients,” said FDA Commissioner Scott Gottlieb, M.D. [Read more…]

FDA Regulation of Cellular and Tissue-Based Products with Dr. Riam Shammaa

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In this interview with Dr. Riam Shammaa, Medical Director at the Canadian Centres for Regenerative Therapy (CCRT), we discuss FDA regulation of human cells, tissues, and cellular and tissue-based products (HCT/P’s), as well as the difference between 351 and 361 products. This is a timely interview, because the U.S. FDA recently filed two federal complaints seeking “permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice requirements.”

The first FDA injunction was against US Stem Cell Clinic LLC of Sunrise, Florida, its CSO Kristin Comella and Co-Owner Theodore Gradel. The second injunction was against Drs. Elliot  Lander and Mark Berman, who control the operations of approximately 100 for-profit affiliate clinics, including the California Stem Cell Treatment Center.

While the FDA has a critical role in market oversight, individual market participants are also responsible for understanding the regulatory framework affecting the sale, distribution, and utilization of stem cell products. This interview is aimed to help you understand the FDA framework affecting HCT/Ps within the U.S, as well as the framework and recommendations implemented by Health Canada.

[Read more…]

Abeona Becomes First Company to Secure Two RMATs

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Abeona Therapeutics - Sanfilippo Syndrome TrialAbeona Therapeutics announced the U.S. FDA granted a Regenerative Medicine Advanced Therapy (RMAT) designation to ABO-102, the company’s AAV-mediated gene therapy for the treatment of Sanfilippo syndrome Type A (MPS IIIA), a rare autosomal-recessive lysosomal storage disease.

It was the 16th RMAT designation awarded by the FDA and a landmark achievement in that it makes Abeona the first company to achieve two RMAT designations.

Headquartered in Dallas, TX, Abeona (NASDAQ: ABEO) is a clinical-stage biopharmaceutical company focused on developing novel cell and gene therapies for life-threatening rare genetic diseases. Abeona’s first RMAT designation was for its EB-101 gene therapy for Epidermolysis Bullosa in January 2018. [Read more…]

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