Unbiased Analysis of Today's Healthcare Issues

How to regulate precision medicines

Currently, pharmaceutical treatments that are used in the U.S. need to gain an approval from the FDA. ¬†The FDA’s approval is contingent on a demonstration of efficacy and safety in a randomized controlled trial (RCT). ¬†However, precision medicine makes the standard FDA approval problematic. As described in Breckenridge et al. (2016), in the precision medicine […]

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