Late on Wednesday, U.S. Food and Drug Administration (FDA) Commissioner Marty Makary and Center for Biologics Evaluation & Research (CBER) Director Vinay Prasad published an article in the New England ...
The US Food and Drug Administration (FDA) is proposing a new “plausible mechanism” pathway that will enable the limited approval of bespoke therapies when randomized trials are impractical. FDA will ...
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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