FDA and CMS move to speed custom gene therapies for rare diseases
Published
The FDA released draft guidance that would let one approval cover patient-specific gene-editing treatments within set limits, so new versions might not need fresh trials. CMS also plans to expand its Medicaid cell and gene therapy payment model beyond sickle cell disease. The guidance is a draft open for comment, not a final rule.
Source: HHS
This is a plain-language summary. Read the original source for full details.