How Can Policymakers Bridge the Gap Between Precision Medicine and FDA Regulation?

Peter Huber and Paul Howard of the Manhattan Institute for Policy Research analyze the disjuncture between biomarker science, which has tremendous potential for catalyzing precision medicine, and FDA’s current capacity to incorporate biomarkers into the regulatory procedures for drug approval. The authors argue that FDA policy is significantly stalling the development of important drugs, and offer recommendations for developing and implementing evidentiary standards that can expedite review and approval of biomarkers for drug development.

This piece originally appeared in Volume 5, issue 7 of Food and Drug Policy Forum, and requires paid-subscription to read.

This piece originally appeared in Forbes