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FDA Approval Author: John K. Jenkins, M.D., Director, Office of New Drugs, at FDA’s Center for Drug Evaluation and Research Last Updated: Jan 30, 2014 - 2:56:22 PM

Novel New Drug Approvals

By John K. Jenkins, M.D., Director, Office of New Drugs, at FDA’s Center for Drug Evaluation and Research
Jan 30, 2014 - 2:52:42 PM

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( - Last year marked another strong year for FDA approvals of novel new drugs, known as new molecular entities (NMEs). In 2013, FDA's Center for Drug Evaluation and Research (CDER) approved 27 NMEs last year - about the same as the 26 average NME approvals per year since the beginning of this decade.

More important than the quantity of novel new drugs approved in 2013 is theirquality - and the important new roles many of these drugs can serve in advancing medical care and the health of patients. We now have new safe and effective treatments for a wide range of serious medical conditions, such as late-stage breast cancer, chronic hepatitis C, metastatic melanoma, mantle cell lymphoma, chronic lymphocytic leukemia, homozygous familial hypercholesterolemia, pulmonary arterial hypertension, and many more. Some of these medications offer new hope to patients who previously had few or no treatment options.

Read the entire blog at FDA Voice.


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