CBER (Center for Biologics Evaluation and Research) look at its input for device industry:
This article was originally published in Clinica
FDA's biologics centre is developing metrics for measuring how well it meets the needs of the device companies it regulates. The Center for Biologics Evaluation and Research (CBER) has been criticised for years for its slow review of the blood product devices and other products classified as devices that fall within its purview. At the AdvaMed annual meeting a year ago, the biologics centre insisted that it was reviewing device products on time, but could offer no statistics to back up that claim. Part of the problem is that CBER does not use the same definitions as industry, CBER deputy director Jesse Goodman admitted at this year's AdvaMed annual meeting held earlier this month in Carlsbad, California. CBER met with officials from the device industry on March 1 to talk about "recalibrating the difference in review metrics," he said.
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