FDA Guidances Expand RMAT Definition, Discuss Use Of Novel Trials

Regenerative medicine industry experts praised FDA’s release of two final guidances they say provide welcome clarity for cell and gene therapy developers on how their products can qualify for FDA’s expedited review programs, including through the use of novel clinical trial designs and historical controls, as well as by using a common manufacturing protocol to group data from multiple developers and researchers. One of the two guidances released Friday (Feb. 15) also includes several changes to FDA’s interpretation of the...