Having trouble accessing articles? Reset your cache.

FDA clarifies criteria for 'sameness' of gene therapies

In new draft guidance, FDA clarified its criteria for determining whether a gene therapy is the same as an existing treatment when considering its eligibility for Orphan Drug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

Read the full word article

User Sign In

Trial Subscription

Get a two-week free trial subscription to BioCentury

SIGN UP

Article Purchase

This article may not be distributed to non-subscribers
More Info >PURCHASE