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FDAnews Device Daily Bulletin
Sept. 18, 2012 | Vol. 9 No. 183
EMA Publishes Nine PARs for Ancillary Drugs Included in Medical Devices
In an effort at greater transparency, the European Medicines Agency (EMA) has begun publishing public assessment reports (PAR) for ancillary drug substances incorporated in medical devices. The reports address the substances’ quality and safety and include a clinical benefit/risk profile of their use in the device.
International Medical Device Regulatory Monitor
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