1. Draft Guidance for Industry and Review Staff: Target product profile—A strategic development process Tool,2007
2. Draft Guidance for Industry Format and Content of Proposed Risk Evaluation and Mitigation: Strategies (REMS), REMS assessments, and proposed REMS modifications,2009
3. Guidance for Industry: Development and Use of Risk Minimization Action Plans,2005
4. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use: ICH Harmonized Tripartite Guideline on Pharmaceutical. Development Q8 R2,2009
5. Guidance on PET Drugs: Current Good Manufacturing Practice (CGMP),2009