The FDA explained the best ways gene therapy developers can get products to treat hemophilia, retinal disorders, and rare diseases approved to go on the market in new draft guidance documents it released July 11.
The agency’s move reinforces its sustained support for the technology, a type of regenerative medicine treatment that involves modifying a person’s genes or introducing new ones to treat, prevent, or possibly cure disease, Alliance for Regenerative Medicine and co-founder and senior policy counsel Michael Werner told Bloomberg Law in an interview.
“It’s another very clear statement from the agency, from the highest levels of the ...
Learn more about Bloomberg Law or Log In to keep reading:
See Breaking News in Context
Bloomberg Law provides trusted coverage of current events enhanced with legal analysis.
Already a subscriber?
Log in to keep reading or access research tools and resources.