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    Cell and gene therapies: FDA official on COVID-19 impact

    Speaking at a session on cell and gene therapies at BIO Digital on Monday, a top US Food and Drug Administration (FDA) official discussed the impact of the coronavirus disease (COVID-19) pandemic on the agency’s work related to cell and gene therapies.   “Before the pandemic, we were seeing a huge escalation in the workload that we have to make adjustments for,” said Wilson Bryan, director of the Office of Tissues and Advanced Therapies at the Center for Biologics Eval...
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    As Stem Cell Clinics Proliferate, E&C Leaders Seek to Hear FDA’s Plan

    A bipartisan group of representatives on the Energy & Commerce (E&C) committee sent a letter to US Food and Drug Administration (FDA) Acting Commissioner Ned Sharpless on Thursday seeking more details on the agency’s plan to slow the proliferation of stem cell clinics. While noting that FDA has agreed to exercise enforcement discretion for 36 months in a recent guidance, the letter also explains how CBER Director Peter Marks said in April that industry has shown “mo...
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    FDA Questions Arizona Stem Cell Company

    As part of efforts to crack down on companies selling unapproved stem cell products to treat a variety of diseases and conditions, the US Food and Drug Administration (FDA) on Thursday sent an untitled letter to Arizona-based R3 Stem Cell and its more than 50 affiliate centers or clinics. FDA raises concerns with R3 because its website makes unsubstantiated claims about the stem cell products, which FDA says appear to be human cell, tissue, or cellular or tissue-based p...
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    FDA to Step Up Stem Cell Enforcement, Look Into Pathway for Low-Risk Treatments

    US Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Biologics Evaluation Research (CBER) Director Peter Marks on Wednesday warned that the agency will step up its enforcement efforts against companies illegally marketing stem cell therapies.   Gottlieb and Marks also said the agency will look into new ways to “delineate an efficient development path” for low-risk stem cell therapies being developed by firms that have filed investigational n...
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    Gottlieb, Marks Detail Plans to Advance Development of Cell and Gene Therapies

    US Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Biologics Evaluation and Research (CBER) Director Peter Marks on Tuesday detailed plans for the agency to keep pace with an expected influx of applications for cell and gene therapies over the coming years.   "The FDA is witnessing a surge of cell and gene therapy products entering early development, evidenced by a large upswing in the number of investigational new drug (IND) applications,...
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    FDA Warns Cord Blood Marketer, Reiterates Enforcement Discretion

    The US Food and Drug Administration (FDA) on Thursday released a warning letter sent late last month to San Diego-based umbilical cord blood product producer Genetech for selling unapproved products. The warning letter comes as FDA and the Centers for Disease Control and Prevention have received numerous reports of safety issues including those involving microbial contamination and are aware of 12 patients who received Genetech products and subsequently became ill due t...
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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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    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 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...