EMA Consults On Data Requirements For Cell And Gene Therapy Trials
The European Medicines Agency's draft guideline on investigational advanced therapy medicinal products makes a clear distinction between exploratory and confirmatory clinical trials as the classical approach of distinguishing between various stages of a clinical trial is not as well defined for such products.
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The 2020 work plan of the European Medicines Agency’s Committee on Advanced Therapies includes initiatives to support the implementation of the EU regulations on medical devices and IVDs.
The 2020 work plan of the European Medicines Agency’s committee on advanced therapies shows that two keenly-awaited guidelines are due to be finalized this year.
Janet Lambert, CEO of the Alliance of Regenerative Medicines recently spoke to In Vivo about the tremendous levels of investment the cell and gene therapy industries are attracting, as well as reasons why Europe excels at incubating advanced product development.