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- MDCG issues guidance on clinical evidence for orphan in-vitro diagnosticsThe Medical Device Coordination Group (MDCG) has published new guidance that explains how clinical evidence requirements apply to orphan in-vitro diagnostics (IVDs). The document is intended to he…
- FDA releases draft guidance on oversight of individualized gene-editing productsThe U.S. Food and Drug Administration issued draft guidance that outlines a proposed regulatory framework for individualized gene‑editing products, including cases where multiple product variants a…