Humacyte's bioengineered blood vessel, Humacyl, demonstrated long-term potency in Phase II studies; the product, which will regulated as a biologic, can now benefit from increased interactions with FDA under the the Regenerative Medicine Advanced Therapy program.
With the help of a quick response from the US FDA, Humacyte Inc. appears to have become the first company to receive a Regenerative Medicine Advanced Therapy (RMAT) designation from the agency for its investigational human acellular vessel Humacyl.
Although FDA is not able to explicitly confirm whether the RMAT designation was the first issued, Center for Biologics and...
In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.
Long-term follow-up requirements have taken a conservative approach but could be ripe for re-examination and global harmonization given the years of experience with the products, Kite Pharma executive director says; former FDA gene/cell therapy office head Wilson Bryan calls for elimination of the classwide REMS.
Program for collaborative reviews of gene therapy applications is getting under way with the European Medicines Agency. After launch, the pilot could be expanded to earlier discussions around CMC and pharm/tox data requirements, FDA’s Nicole Verdun said.
