I apologize if some of my columns over the years have seemed a bit negative or critical. As a publication, we started up at a time when thought leaders pointed out the seemingly limitless potential to improve and modernize manufacturing.

Pop quiz! Where did the following snippets from FDA citations come from? (Winner gets a free coffee mug, runner up gets two -:))Contamination during the manufacture of serum injectables?Failure to measure or account for endotoxins? Failure to respond to adverse patient reactions? Presence of vermin and unsanitary conditions at the...

This just in from FDA....

We wanted to criticize, in as forceful and graphic a way as possible, the cynical attitude of the compounding facility management, to call attention to the disgraceful conditions that were found at many of the compounding facilities that were inspected, and also to draw some attention to the political situation (e.g.

Just received confirmation of last post. Here's the official letter announcing changes from CDER Director, Dr. Janet Woodcock

Haven't confirmed any of this yet, but just heard rumors of change, and another 'superoffice' restructuring at FDA. Apparently, within the new framework, the Office of Generic Drugs will become a "superoffice", OPS will be no more, while OMPQ, ONDQA and OBP will report to OPQ.

Four Reasons Why You Should Do it, Three Reasons Why You're Not

On Monday, June 18th, BIO 2012 was much more subdued than I’d remembered seeing it in the past. However, it was just the first official day, and a number of breakout sessions touched on important topics.

At the ISPE/FDA conference on cGMP’s in Baltimore last week, Andrew Skibo, EVP of operations and manufacturing at MedImmune, spoke on the topic of “High Quality in a Lean Manufacturing World.” The pharmaceutical industry’s increasing focus on reducing manufacturing costs, he said, has come at a time when the industry...

Those who cover green and sustainability issues know that Pharma is pretty progressive. No, the industry's not perfect, certainly, but many of its leading companies also make it a point to be leaders in environmental stewardship.