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After a bit of a lull, the U.S. Food and Drug Administration (FDA) issued a batch of warning letters focused on pharmaceutical manufacturing quality issues in the first quarter of 2017. Examples [...]

FDA’s Center for Devices and Radiological Health (CDRH) provided a glowing self-assessment in a recent report. The CDRH met its 2016 strategic objectives for several initiatives pertaining [...]

If working with the FDA sometimes feels like reading tea leaves the Quarterly Update on Medical Device Performance Goals gives us more than our usual share of relatively hard data.