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Home » Bureaucracy Within FDA Delays Some Combination Product Reviews
Bureaucracy Within FDA Delays Some Combination Product Reviews
When the FDA is reviewing products that include both drugs and devices in combination, a stumbling block that sometimes causes delays is poor communication between the agency's Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH), according to an independent assessment by Lexington, Mass.-based Eastern Research Group (ERG).