• Regulatory NewsRegulatory News

    In US, unlicensed stem cell clinic numbers keep climbing

    Nearly 1,500 US businesses were engaged in direct-to-consumer marketing of unproven and unlicensed stem cell therapies in 2021, marking a significant uptick over the last five years.   The figure comes from an analysis published in the journal Cell Stem Cell that breaks down the number of clinics promoting various types of putative stem cell treatments in the United States between 2016 and 2021. As of March 31, 2021, there were 1,480 U.S. business operating 2,754 c...
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    Two more stem cell firms slapped with untitled letters

    Untitled letters issued to two firms for marketing unapproved stem cell products signal that some in the industry are undeterred by the US Food and Drug Administration’s (FDA) efforts to get these products approved or off the market.       The letters join four others from the Center for Biologics Evaluation and Research (CBER) in recent months to clinics marketing unapproved stem cell products after an enforcement grace period ended on 1 June. (RELATED: CBER targets...
  • Regulatory NewsRegulatory News

    CBER targets four stem cell firms with untitled letters

    The US Food and Drug Administration’s Center for Biologics Evaluation and Research (FDA’s CBER) recently issued untitled letters to four companies for marketing unapproved stem cell products, indicating that despite the end of an enforcement grace period, companies are still resisting the agency’s efforts to get these products approved.   Effective June 1, companies are required to file biologics license applications for stem cell therapies that claim to treat a diseas...
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    CBER Q&A addresses stem cell enforcement questions

    The US Food and Drug Administration (FDA) issued a question-and-answer document on Monday to address issues that may arise now that the agency's enforcement discretion policy against unauthorized marketing of these products has come to an end.   The agency’s Center for Biologics Evaluation and Research (CBER) ended a period of enforcement discretion against purveyors of unauthorized human cells, tissues, or cellular or tissue- based products (HCT/Ps) on 31 May 2021. Ac...
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    FDA disappointed with slow uptake of approvals for stem cell therapies

    At a recent meeting, a US Food and Drug Administration official said the agency is “concerned” about the slow uptake from companies seeking regulatory approval to market and distribute stem cell therapies and is therefore stepping up their enforcement efforts against companies making unapproved therapies.   Wilson Bryan, director of FDA’s Office of Tissues and Advanced Therapies (OTAT) in FDA’s Center for Biologics Evaluation and Research, told attendees of an 8 June m...
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    Time's up for questionable cell and tissue products, says Marks

    Purveyors of unapproved cellular-derived treatments are about to find out what happens when the US Food and Drug Administration ends its period of enforcement discretion for these regenerative medicine products.   A three-year clock for enforcement discretion began when FDA announced its regenerative medicine policy framework in November 2017; the COVID-19 pandemic prompted a 6-month extension, announced the agency last summer. Time is now up, and no more extensions ...
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    FDA Puts Opioids, Compounding, Stem Cells at Forefront of Enforcement Efforts

    The US opioid epidemic, drug compounding and the proliferation of stem cell clinics selling unproven treatments were highlighted as some of the focal points for US Food and Drug Administration (FDA) enforcement efforts last year and next year, officials said Wednesday at the Food and Drug Law Institute’s litigation and compliance conference in Washington, D.C. Becky Wood, chief counsel for FDA, keynoted the conference and discussed the opioid crisis, and in particul...
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    Asia Regulatory Roundup: India Tightens Stem Cell Guidelines (17 September 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Tightens Stem Cell Guidelines to Curb ‘Rampant’ Unethical Therapeutic Practices India has tightened its guidelines on the banking and therapeutic use of stem cells in response to “rampant unethical practices.” The updated guidelines strengthen mechanisms for the review and monitoring of stem cell clinical trials and prohibit commercial banking of most biological ...
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    New California Law Requires Posted Notices of Non-FDA Approved Stem Cell Products

    California Gov. Jerry Brown this week signed into law a bill that requires health providers to post notices in their offices when they are administering stem cell treatments that have not been approved by the US Food and Drug Administration (FDA). The law is part of efforts to crack down on the use and sale of unapproved stem cell treatments, some of which are being hawked as cures for a range of diseases with few or no treatment options, like ALS, autism and spina...
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    New Texas Law on Stem Cell Treatments: Showdown With FDA Coming?

    With a new Texas law now in the books to allow companies to sell unproven stem cell treatments without US Food and Drug Administration (FDA) approval, some experts wonder when FDA will step in to shut down companies and clinics exposing people to unapproved medical products. Similar to the “Right to Try” laws spreading across the US and attempting to undercut FDA’s regulation of investigational products, the Texas law , which had been brewing in some form since...
  • Feature ArticlesFeature Articles

    Is the Current Regulation of Autologous Stem Cells Appropriate?

    This article discusses the regulation of autologous stem cells and tissue therapies in Australia by addressing issues such as the safety and efficacy of cell therapies, which therapies are regulated, what regulators are doing in other countries and "next steps" in cell and tissue regulation. Introduction The Therapeutic Goods Administration (TGA), the regulating body in Australia, is the division of the Australian government Department of Health responsible for regul...
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    Asia Regulatory Roundup: India’s DCGI Orders Manufacturers to Assess GMP, GLP Compliance (30 August 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. DCGI Orders Manufacturers to Assess Their Compliance with GMPs, GLPs The Drug Controller General of India (DCGI) has ordered companies to self-assess their compliance with good manufacturing and laboratory practices (GMPs/GLPs). DCGI is demanding manufacturers carry out the self-assessment, award themselves a quality rating and submit the resulting report to the relev...