Last year, the U.S. Food and Drug Administration approved 41 new drugs and biologics for use in medical treatment, the highest number of approvals in 18 years. And yet despite this high, the output of new drugs over the past several decades has demonstrated fluctuating yet flat trends in number of approvals. At the same time, pharmaceutical industry R&D spending continues to rise dramatically, leading many to question the efficiency of the drug development and regulatory review process.
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