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  • Regulatory NewsRegulatory News

    European Commission Updates Borderline Device Classification Manual

    The European Commission (EC) last week released an update to its manual on classifying "borderline" medical devices featuring clarifications as to the medical device status and classification of on twelve additional types of products. The manual, which is now in its eighteenth version, is meant to serve as a tool or reference for case-by-case device determinations, though the recommendations in the manual are not legally binding and such decisions are ultimately up to na...
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    FDA Warns Stem Cell Supplier Over Unapproved Treatment

    The US Food and Drug Administration (FDA) on Wednesday warned stem cell product supplier American CryoStem Corporation for marketing an unapproved product after the agency inspected the company's Eatontown, New Jersey site in July. The warning letter comes just months after FDA announced a new framework for regulating regenerative medicines that included a 36-month period of enforcement discretion by the agency, though at the time, an FDA spokesperson told Focus the ...
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    Devices Referencing Drugs: Questions Raised Over Potential Regulatory Pathways

    The US Food and Drug Administration (FDA) on Thursday held a public hearing to look into the scientific, regulatory and legal challenges posed by devices referencing drugs (DRDs) and the agency's proposed approach to regulating such products. Specifically, DRDs are medical devices that reference an already-marketed drug when the drugmaker does not want to work with the device sponsor to pursue the new use. FDA says it sees three situations where DRDs could be proposed: ...
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    European Regulatory Roundup: Rise of Cell Therapies Prompts EC to Float Orphan Drug Changes (2 November 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Rise of Cell Therapies Prompts Commission to Float Changes to Orphan Drug Rules The European Commission has proposed changes to its orphan drug regulation. Officials want to make changes to the 17-year-old text to account for the rise of cell therapies and other advanced medicinal products, the nature of which are a poor fit for aspects of the existing regulation. If t...
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    Asia Regulatory Roundup: Australia’s TGA to Tighten Regulation of Autologous Cell Products, Ban Ads (31 October 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA to Tighten Regulation of Autologous Cell Products, Ban Advertisements The Therapeutic Goods Administration (TGA) is planning to tighten oversight of autologous cell and tissue products. TGA’s proposed changes will bring some therapies under the biologicals regulatory framework, ban direct-to-consumer advertising and generally move Australia more in line with the ...
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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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    FDA Finalizes Combination Product Classification Guidance

    The US Food and Drug Administration (FDA) on Tuesday issued its final guidance on classifying combination products as drugs, biologics or medical devices. The guidance finalizes and combines two 2011 draft guidances, Classification of Products as Drugs and Devices & Additional Product Classification Issues and Interpretation of the Term 'Chemical Action' in the Definition of Device Under Section 201(h) of the Federal Food, Drug and Cosmetic Act , and details how F...
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    FDA to Unveil New Regulatory Framework for Stem Cell Therapies

    The US Food and Drug Administration's (FDA) Commissioner Scott Gottlieb said Monday the agency will advance a new framework to better regulate stem cell therapies this fall. "This comprehensive policy will establish clearer lines around when these regenerative medicine products have sufficient complexity to fall under the agency's current authority, and then define an efficient process for how these products should be evaluated for safety and effectiveness," Gottli...
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    FDA Panel Votes Unanimously in Favor of First CAR-T Cancer Therapy

    The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee on Wednesday voted unanimously, 10 to 0, in favor of the benefit-risk profile for the first of a new kind of cancer therapy, known as a Chimeric Antigen Receptor T-cell (CAR-T) therapy. Although the outside panel of experts raised questions about concerns with the safety and manufacturing of the Novartis treatment, known as CTL019 (tisagenlecleucel-T), the panel did not question the effi...
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    FDA Approves First New Sickle Cell Drug in Almost 20 Years

    The US Food and Drug Administration (FDA) on Friday granted approval to Emmaus Medical’s Endari (L-glutamine oral powder), the first treatment approved for patients with sickle cell disease in almost 20 years. Endari is approved for patients age five years and older with sickle cell disease to reduce severe complications associated with the blood disorder. Endari is the 24th new drug approved by FDA in 2017, already two more than all of 2016 . Richard Pazdur...
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    CDC National Stockpile of Medical Products Could be at Risk in Public Health Emergency

    The US Department of Health and Human Services’ Office of Inspector General (OIG) warns that "systemic issues" with the Centers for Disease Control and Prevention’s (CDC) stockpile of vaccines, antibiotics, antidotes, antitoxins, medications and other supplies could place at risk approximately $7 billion of inventory and negatively affect readiness during a national emergency. Background Created in 1999, the stockpile is meant to supplement and resupply state and...
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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...