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October 24, 2016
The Alliance submitted comments to the FDA on its draft guidance "Use of Real World Evidence to Support Regulatory Decision-making for Medical Devices." The Alliance voiced support for the use of data from registries, claims, and electronic health records when evaluating medical devices. Comments also addressed the limitations of randomized clinical trials in evaluating the effectiveness of a wound care product. The Alliance provided specific examples of how registry data could be used in assessing the safety of a wound care medical device.

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