About six years ago, I wrote an editorial describing my skepticism over FDA’s plans to incorporate more science into its regulatory oversight. At that time, the industry had just been introduced to the concepts of the new risk-based initiative, and Pharm Tech received regular inquiries about “this PAT we keep hearing about.” Companies complained that good science was being suppressed by strict adherence to traditional processing and analytical methods. “Alternative” methods were definately discouraged, even if it was well known that the technologies were more efficient. I had my doubts about the agency’s promises to let good science lead the lead to greater regulatory flexibility. Now I’m happy to eat my words.Facing a large number of its staff near retirement, and just three weeks after receiving confirmation of a $150 million federal grant, FDA is starting a two-year fellowship program for future investigators and perhaps industry personnel. The first wave of 30-40 participants will begin in October. This is good news for the industry. I’ve heard industry scientists complain that one of the biggest obstacles to true change is their coworkers and managers and their insistence on sticking to traditional means. Perhaps this program will help bring on a new level of collaboration between industry and regulators who are open to new ideas. The industry will remain a highly conservative industry, as it should, but seeds of innovation should at least have a start. I would hope participants are given the opportunity to experience the “real-world” industry application of their coursework and actual production processes. Take a look at the coursework and tell us what you think.