The Key to Improving Quality Culture

Culture.  With regards to the FDA, this word typically refers to growing microorganisms or other living materials in a medium.  You will also find the word “culture” in The FDA’s Draft Guidance for the “Request for Quality Metrics.”  The word is used 10 times in...

Blue Mountain Applauds the Cancer Moonshot

President Obama announced at the last State of the Union Address that Vice President, Joe Biden, will officially be leading the “moonshot” against cancer. Biden accepted this task, as a tribute to his son, Beau, who died of brain cancer this past May. On the day of...

FDA’s Proposed Quality Metrics Guidance

As we’ve heard since 2013, the FDA will soon require quality metrics to be submitted for certain product types. There is no better summary of what the FDA hopes to achieve, than a quote taken from an FDA PowerPoint: “A maximally efficient, agile, flexible...