Can Lean Negate Quality Control? Lessons From Fallen Lean Icons Toyota and J&J

Dialogue with FDA: Can You Speak the Language?

Change: It’s Coming (or “I’ll Get Agile… Mañana”)

Go Out and Gemba

Excipient Inspection and Standard-Setting: A New Role for a High-Level FDA Alumnus?

Pillbox, NIH's Physician’s Desk Reference on Steroids

Mylan Labs and Pharma's Little Chernobyls

FDA Commissioner Hamburg on Enforcement: "My Own Naivete May Move Things Forward"