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- Euro Roundup: EMA seeks feedback on framework designed to drive uptake of data standardsThe European Medicines Agency (EMA) is holding a consultation about a draft framework intended to cut the time it takes to implement data standards.raps · 1d ago↗ source
- Experts discusses need to modernize evidentiary models in rare diseasesUsing the US Food and Drug Administration’s (FDA) plausible mechanism framework to allow for greater use of causal inference may help with evidence generation for rare diseases, according to a rece…raps · 1d ago↗ source
- FDA finalizes Q&A guidance on developing cell and gene therapiesThe US Food and Drug Administration (FDA) on Wednesday finalized guidance addressing frequently asked questions related to the development of cellular and gene therapy (CGT) products.