FDA chief warns U.S. is losing ground to China in early drug development, calls for faster trial approvals [CNBC]
Morgan Stanley (MS)
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Source: CNBC
and called for reforms that could streamline the process for starting trials on new treatments. In an interview with CNBC on Wednesday, Makary specifically pointed to three bottlenecks: hospital contracting, ethical reviews and approvals, and the process for submitting and clearing so-called Investigational New Drug applications, which companies submit to test a product in humans. China's biotech ecosystem has flourished over the last several years, driven by massive state investment, a vast talent pool and accelerated regulatory reforms. Food and Drug Administration Commissioner Marty Makary warned that the U.S. is falling behind China in early-stage drug development and called for reforms that could streamline the process for starting trials on new treatments. In an interview with CNBC on Wednesday, Makary specifically pointed to three bottlenecks that he said cause the U.S. to fall behind on those early drug trials. That includes hospital contracting as well as ethical re
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