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US Critical Path Initiative "gives inadequate attention device sector"

This article was originally published in Clinica

Executive Summary

The FDA's much-vaunted critical path initiative (CPI), which strives to bring the tools used for medical product development into the 21st century, has come under fire both internally and externally for putting too much emphasis on the needs of the pharmaceutical industry at the expense of the device industry. The evidence for this mismatch is both symbolic and substantive, critics say.

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