Well, this is getting interesting. For the past several months, we’ve had relatively partisan folks on each side of the medical device industry vs.

With the explosive growth in imported goods to the United States, what is the Food and Drug Administration (FDA) doing toward maintaining a level of service inspection that ensures the best protection of the public health?

Just when you think that the Food and Drug Administration (FDA) has to stick to the script by quoting chapter and verse of current Good Manufacturing Practices (CGMPs), it gets very progressive and offers straight talk about corporate commitment and leadership.

There is a new international standard published June 9, 2011, that might just warrant your attention.

Keith Greenaway, vice president of ACLASS, a brand of ANSI-ASQ National Accreditation Board that provides accreditation, gave a brief talk titled “Focus on Inspections and Compliance” at the FDA Food Safety Modernization Act public meeting held on June 6, 2011.

I don’t know how I missed this gem, but on March 24, 2011, the Food and Drug Administration (FDA) sent a Warning Letter to Jonathan’s Sprouts Inc.

“We can do better” was the underlying takeaway message from the 15th annual Mayo Clinic Quality Conference. This year’s theme was “Creating and Paying for Value in Health Care.”

Last month I wrote an article entitled “Being Comfortable in a World of Never-Ending Change.” Editor in Chief Dirk Dusharme and I also covered this story on t

About six years ago I was meeting with a clinical team to kick off an early improvement effort at their hospital. We began with a reflection on the problems with traditional business management practices.

Can you imagine the stream of firms that venture into their respective FDA district offices to give presentations on their warning letter response and to offer their assurance that they truly “get it?” You can be sure these firms had several dry runs and dress rehear