Personalized Medicine at FDA: 2016 Progress Report


If new drug approvals are any indication, personalized medicine is progressing steadily despite ongoing challenges in regulation, reimbursement and clinical adoption. The Personalized Medicine Coalition (PMC)’s latest analysis shows that in 2016, for the third year in a row, personalized medicines accounted for more than 20 percent of all new molecular entities (NMEs) the agency approved. FDA’s Center for Drug Evaluation and Research (CDER) approved 22 NMEs, new drugs, agents or therapeutic biologics, in 2016.

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