FDA Commissioner Marty Makary and Vinay Prasad, FDA’s chief medical and scientific officer and director of the agency’s Center for Biologics Evaluation and Research, jointly published a letter in The New England Journal of Medicine spelling out the rationale for FDA’s new “plausible mechanism pathway,” aimed at getting bespoke therapies to market without the need for a randomized controlled trial.
Boca Raton resident Gabriela Sanchez recently found herself stepping into a mobile outreach vehicle operated by Sylvester Comprehensive Cancer Center.
