ISSCR News
The ISSCR Comments on EMA Draft Guidance on Registry-based Studies
The ISSCR recently delivered comments on the draft Guideline on Registry-based Studies (EMA/502388/2020). Among other points, the letter stated support the crucial role of the European Medicines Agency (EMA) in overseeing the development of safe and effective new products and the draft Guideline on Registry-based Studies. The Society also encouraged EMA to clarify the appropriate uses for patient registries to prevent them from being abused by businesses seeking to prematurely commercialize unproven stem cell-based interventions.
The ISSCR Leads Coalition Letter to President-elect Biden on Human Fetal Tissue Research
The ISSCR and a coalition of 98 scientific, medical, and patient communities dedicated to advancing medical knowledge and improving human health urged President-elect Biden to swiftly rescind the human fetal tissue (HFT) research restrictions and policy changes that the Department of Health and Human Services made in 2019. Among other key points, the letter stated that these changes have halted all intramural HFT research and obstructed new extramural research involving HFT. Scientists and ethicists have repeatedly reviewed the use of HFT in research and have consistently concluded that HFT is an essential resource for biomedical research. HFT has led to many scientific and medical advances that have saved millions of lives. It remains critical for the development of new treatments for a wide range of serious diseases, including COVID-19.
The ISSCR Shared Comments on Hong Kong’s Draft Guidance for Cell and Tissue Products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.
The ISSCR Signs Ad Hoc Group for Medical Research Coalition Letter on NIH to President-elect Biden
The ISSCR joined with the Ad Hoc Group for Medical Research and 349 member organizations representing patients, clinicians, scientists, educators, academic institutions, research organizations, and industry, in a letter thanking President-elect Joseph R. Biden, Jr. for his steadfast support for science. The letter states, "As the oldest coalition advocating for the federal investment in the National Institutes of Health (NIH) and biomedical, bioengineering, behavioral, and social science research, we are grateful that you support increased and sustainable funding growth for the NIH as part of $300 billion in new research and development investments in your Build Back Better plan."
The ISSCR Shares Comments on the European Medicines Agency's Network Strategy to 2025
The ISSCR shared comments with the European Medicines Agency (EMA) related to its Network Strategy 2025. This included support for the crucial role of EMA and national regulators in overseeing the development of new products and offer a few recommendations to ensure that new products are proven safe and effective before being marketed to patients.
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