1. Healthy innovation, safer families: FDA’s 2018 strategic policy roadmapstrategic policy roadmap;FDA,2018
2. Labeling for human prescription drug and biological products – Implementing the PLR content and format requirements;FDA,2013
3. The New Food and Drug Administration Drug Package Insert: implications for patient safety and clinical care;Watson;Anesthesia Analgesia,2009
4. The package insert: who writes it and why, what are its implications, and how well does medical school explain it?;McMahon;J Psychiatric Pract,2014
5. Warnings and precautions, contraindications, and boxed warning sections of labeling for human prescription drug and biological products—Content and format;FDA,2011