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PMC Analysis: More Than 20 Percent of FDA's 2014 Novel New Drug Approvals are Personalized Medicines

WASHINGTON (Jan. 28, 2015)


The Personalized Medicine Coalition (PMC) has concluded its first full assessment of the Novel New Drugs approved by the FDA’s Center for Drug Evaluation and Research (CDER) in 2014. The results show that more than 20 percent of the 2014 approvals were personalized medicines.

PMC President Edward Abrahams noted, "We applaud FDA's commitment to ensure that patients have access to novel personalized medicines that improve health and can also lower overall costs."

“We have gone from one or two targeted drugs approved each year to a significant amount in 2014,”stated Daryl Pritchard, Ph.D., vice president, science policy, PMC. “It is clear that personalized medicine is increasingly becoming an integral part of clinical care and we expect this trend to continue along with greater recognition of the value of personalized medicine by payers and providers.” 

To carry out its assessment, PMC has undertaken a rigorous review of available data provided by the FDA regarding 2014 approved products.  This effort was guided by the PMC definition of personalized medicine -- product labels need to refer to a specific biomarker that can play a role in treatment decision making, either whether or not to treat, or how to treat, for an individual patient. 

Personalized medicine:

An emerging field that uses diagnostic tools to identify specific biological markers, often genetic, to help determine which medical treatments and procedures will be best for each patient. By combining this information with an individual’s medical records and circumstances, personalized medicine allows doctors and patients to develop targeted prevention and treatment plans. The goal is to provide the right treatment in the right dose to the right patient at the right time. 

Issue brief on PMC evaluation of FDA novel new drug approvals including list of 2014 personalized medicines

FDA CDER 2014 approvals


Chris Wells
Phone: 202-580-9780

About the Personalized Medicine Coalition:
The Personalized Medicine Coalition (PMC), representing innovators, scientists, patients, providers and payers, promotes the understanding and adoption of personalized medicine concepts, services and products to benefit patients and the health system. For more information about PMC, visit

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