FDA, CMS advance policy for personalized gene therapies
The FDA has issued draft guidance for developers of personalized genome editing therapies for rare genetic diseases, and CMS said it will expand its Cell and Gene Therapy Access Model beyond sickle cell disease. The FDA’s guidance, “Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management,” covers how to structure a biologics […] The post FDA, CMS advance policy for personalized gene therapies appeared first on Becker...
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