1. Taste of raspberries, taste of death: the 1937 elixir sulfanilamide incident;Ballentine;FDA Consum. Mag.,1981
2. Management-based Regulation Prescribing Private Management to Achieve Public Goals;Coglianese,2003
3. Performance-based Regulation: Concepts and Challenges. Comparative Law and Regulation: Understanding the Global Regulatory Process;Coglianese,2016
4. Pharmaceutical CGMPs for the 21st Century – a Risk-Based Approach;FDA,2004
5. PAT—a Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance;FDA,2004