1. Note for guidance on clinical investigation of medicinal products in the paediatric population;EMA,2001
2. Pediatric study plans: content of and process for submitting initial pediatric study plans and amended initial pediatric study plans guidance for industry;FDA,2016
3. Paediatric drug development: the impact of evolving regulations;Turner;Adv Drug Deliv Rev,2014
4. Successes of the Paediatric Regulation after 5 years. August 2007–December 2012;EMA,2013
5. Impact of pediatric exclusivity on drug labeling and demonstrations of efficacy;Wharton;Pediatrics,2014