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- FDA issues draft guidance for electronic IDE submissions via eSTARThe U.S. Food and Drug Administration released draft guidance outlining how sponsors can submit investigational device exemption (IDE) applications using the electronic Submission Template and Reso…
- FDA releases draft guidance on oversight of individualized gene-editing productsThe U.S. Food and Drug Administration issued draft guidance that outlines a proposed regulatory framework for individualized gene‑editing products, including cases where multiple product variants a…