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TOPIC: FDA Acts on Illegal Stem Cell Clinics - It's About Time!

FDA Acts on Illegal Stem Cell Clinics - It's About Time! 17 May 2018 13:55 #11797

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The Alliance for Regenerative Medicine Applauds FDA's Actions Against Unregulated Stem Cell Clinics

WASHINGTON, D.C., May 15, 2018, - The Alliance for Regenerative Medicine, along with sector colleagues ISCT and ISSCR, applauds last week’s actions by the FDA to stop two unregulated stem cell clinics from marketing and delivering unapproved stem cell products, and for violating current good manufacturing practice requirements. Such action is necessary to protect the health and safety of patients from unscrupulous actors touting unproven clinical benefits, maintaining insufficient sterility standards, and worse.

ARM has steadfastly contended that in order to fully realize the significant promise of potentially curative cell and gene therapies, all product candidates, including all those of ARM members, must undergo the appropriate, scientifically-rigorous approval process overseen by an internationally recognized regulatory authority, such as the U.S. FDA. The FDA, with its mission to uphold public trust, must continue to monitor and, when necessary, apply strong and swift legal action to uphold the strictest standards for patient safety and product efficacy.

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FDA Acts on Illegal Stem Cell Clinics - It's About Time! 17 May 2018 14:25 #11799

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Wall Street Titan wrote: The Alliance for Regenerative Medicine Applauds FDA's Actions Against Unregulated Stem Cell Clinics

WASHINGTON, D.C., May 15, 2018, - The Alliance for Regenerative Medicine, along with sector colleagues ISCT and ISSCR, applauds last week’s actions by the FDA to stop two unregulated stem cell clinics from marketing and delivering unapproved stem cell products, and for violating current good manufacturing practice requirements. Such action is necessary to protect the health and safety of patients from unscrupulous actors touting unproven clinical benefits, maintaining insufficient sterility standards, and worse.

ARM has steadfastly contended that in order to fully realize the significant promise of potentially curative cell and gene therapies, all product candidates, including all those of ARM members, must undergo the appropriate, scientifically-rigorous approval process overseen by an internationally recognized regulatory authority, such as the U.S. FDA. The FDA, with its mission to uphold public trust, must continue to monitor and, when necessary, apply strong and swift legal action to uphold the strictest standards for patient safety and product efficacy.


The FDA action is old news from last week, but thanks for the contribution.

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