Attorneys Praise FDA For Assuaging Concerns Over Gene Therapies' Eligibility For RMAT

A recently released draft guidance outlining the potential expedited pathways available to gene therapy sponsors assuaged concerns that therapies promising solely durable, rather than permanent, changes in a patient may not be eligible for the 21st Century Cures-created Regenerative Medicine Advanced Therapy (RMAT) designation, according to a new blog from attorneys at Hogan Lovells. The guidance, also clarifies that both ex-vivo gene therapies, like the two FDA-approved products to date, as well as in-vivo therapies will be eligible for the...