MedPage Today on MSN
FDA proposes new approval pathway for rare disease gene therapy
Will consider data that includes "the experience of individuals," FDA commissioner says ...
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teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...
The Food and Drug Administration (FDA) announced a new proposal Monday for flexible drug approval pathway treatments ...
Clinical Trials Arena on MSN
Gene editing takes centre stage in FDA’s new rare disease approval pathway
The aim of the pathway is to remove red tape for bespoke therapies designed for patients with rare diseases.
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 ...
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