Will consider data that includes "the experience of individuals," FDA commissioner says ...

The FDA guidelines aim to create a new pathway for bespoke therapies due to the challenges of conducting large studies.

After teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...

Urnov is a professor of molecular therapeutics at the University of California, Berkeley, and a director at its Innovative Genomics Institute. In May, news broke of a biomedical first: the on-demand ...

In a highly anticipated article, FDA officials Vinay Prasad, M.D., and Martin Makary, M.D., outlined a novel regulatory pathway that could trigger a seismic shift in how bespoke gene editing therapies ...

“Companies should really sit down and say, could I meet these points?” Hogan Lovells partner Lynn Mehler said. “How do I follow the larger concept at play here, which is FDA willingness to be ...