ISSCR News
ISSCR Shares Concerns Regarding New Google Ads Policy
…the ISSCR is concerned that unscrupulous clinics may misuse the update to Google’s policy by promoting unproven therapies under the guise of distributing material that is “exclusively educational or informational in nature.” If so, this would harm consumers and public health.
The ISSCR Comments on Draft Guidance from FDA - Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products
The ISSCR shared comments on draft guidance from the FDA's Center for Biologics Evaluation and Research (CBER) (Docket No. FDA2021-D-1146) Real-World Data: Assessing Registries to Support Regulatory Decision Making for Drug and Biological Products.
The ISSCR Comments on Public and Stakeholder Consultations for the Revision of the EU BTC Legislation
The ISSCR shared its comments on public and stakeholder consultations for the revision of the European Union’s (EU) legislation on blood, tissues, and cells (BTC) with the Directorate-General for Health and Food SafetyEuropean Commission.
The ISSCR Shared Comments on Hong Kong’s Draft Guidance for Cell and Tissue Products
The ISSCR condemns the premature commercialization of unproven cell therapies, which has resulted in patients being blinded, paralyzed, and infected with dangerous pathogens. In many countries, unscrupulous businesses marketing these unproven cell therapies have abused ambiguous definitions for substantial/minimal manipulation and homologous use to claim they are not subject to oversight. Regulators around the world need to adopt harmonized product definitions to protect public health and to prevent the premature commercialization of stem cell-based products.
ISSCR Applauds Australia’s Move to Regulate Autologous Human Cell and Tissue Products
The ISSCR appreciates the new framework proposed by Australia’s Therapeutic Goods Administration (TGA) for the regulation of human cell and tissue products that use a person’s own cells (‘autologous use’). These new regulations are meant to halt the marketing and administration of unproven cell therapies that have not been proven safe or effective. Sales of these products by unscrupulous clinics to desperate patients have been increasing in recent years. Recently, these products resulted in the death of an Australian patient and the blinding of three patients in the United States.
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