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- FDA issues revised draft guidance for drug-device combination product performanceThe U.S. Food and Drug Administration has released a revised draft guidance aimed at helping sponsors of drug-device combination products develop essential drug delivery device performance characte…
- FDA outlines pathway for approval of personalized gene-editing therapiesThe U.S. Food and Drug Administration released a set of recommendations describing how developers can pursue regulatory approval for gene-editing treatments that are customized to a single patient’…