ARTICLE | Clinical News
FDA clarifies criteria for 'sameness' of gene therapies
January 28, 2020 11:17 PM UTC
Updated on Jan 29, 2020 at 1:25 AM UTC
In new draft guidance, FDA clarified its criteria for determining whether a gene therapy is the same as an existing treatment when considering its eligibility for Orphan Drug designation and exclusivity.
The agency said that while prior orphan drug regulations have outlined criteria for sameness in large molecules and other drug types, there was still some ambiguity with respect to how the regulations apply to gene therapies...
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