This just in from FDA....

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

 CDER Staff:

I want to inform you about some important proposed organizational changes for CDER.

Newt Gingrich, Andrew von Eschenbach and Wayne Oliver, of the Center for Health Transformation, wrote a blog post recently that you might find interesting.

Today, Chris Watts, last of the PAT Team leaders to have stayed at FDA, will be leaving the Agency. He has been with FDA for eight years, and plans to return to California, and the San Diego area. Of his stint at the Agency, he writes, "The experience far exceeded my expectations . . . and I can only hope that future opportunities offer as much." Of course, biopharm company recruiters will want to take note that such talent might be available, locally.

Just read Mina Kimes' enlightening account of the J&J McNeil quality disaster in Fortune. Forget about the fact that the adulterated products did not and most likely would not have harmed consumers, the problems cited are very serious and go straight to the heart of GMP's.

At this week's FDA meeting on PAT and QbD, someone in the audience asked CDER Deputy Director Keith Webber, who had spoken about PAT, QbD, process validation (old vs. new) and real time release vs. end of line testing, whether FDA would ever require PAT.

At this week’s PAT/QbD meeting, sponsored by FDA and the University of Rhode Island’s College of Pharmacy, there was no question that the speaker everyone was waiting to hear from was Ajaz Hussain, former PAT team leader, Sandoz executive and now VP at Philip Morris International.

He burst energetically up to the podium, briefly recapping the history of why PAT was advanced. At the time, he said, FDA was resisting ICH Q8, although Europe and Japan were embracing it.

The compliance consultants, Vectech, are now offering virtual cGMP consulting services, to help drug manufacturers deal with FDA compliance questions immediately via videoconferencing. The company is promoting this as a way to eliminate travel costs, yet ensure "face time." Costs are said to be a fraction of what traditional consulting runs. For more, read on.

Last year, I attended FDA’s first science writers’ symposium, an interesting program that I’m looking forward to again this year. I wrote up a brief report on the event and took some very amateur videos of scientists’ presentations, envisioning the construction of some grand documentary on FDA's new lab facilities . . . then, my laptop was stolen during a trip, the article was lost and material never made it onto our web site.