BioSpace

New FDA draft guidance doubles down on expediting approvals of personalized gene therapies

The FDA has outlined a process for allowing a single application to cover multiple variants of a gene therapy. At the same time, the Centers for Medicare & Medicaid Services has revealed plans to expand the Cell and Gene Therapy Access Model to increase patient access to these products.

By BioSpace

1 min read
New FDA draft guidance doubles down on expediting approvals of personalized gene therapies
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