Author:
Donoghue Martha,Ehrlich Lori,Merino Margret,Singh Sonia,Karres Dominik,Ligas Franca,Lesa Giovanni,Reaman Gregory
Publisher
Springer International Publishing
Reference49 articles.
1. Akalu A et al (2021) A review of the experience with pediatric written requests issued for oncology drug products. Pediatr Blood Cancer 68(2):e28828. https://doi.org/10.1002/pbc.28828
2. Ballentine C (1981) Taste of raspberries, taste of death: the 1937 elixir sulfanilamide incident. FDA Consumer Magazine. https://www.fda.gov/about-fda/histories-product-regulation/sulfanilamide-disaster. Accessed 28 Aug 2021
3. Bucci-Rechtweg C (2017) Enhancing the pediatric drug development framework to deliver better pediatric therapies tomorrow. Clin Ther 39(10):1920–1932. https://doi.org/10.1016/j.clinthera.2017.07.043. Epub 2017 Aug 14
4. European Commission (2017) State of paediatric medicines in the EU: 10 years of the EU Paediatric Regulation. https://ec.europa.eu/health/sites/default/files/files/paediatrics/docs/2017_childrensmedicines_report_en.pdf
5. European Medicines Agency (1995–2022) Conditional marketing authorisation. https://www.ema.europa.eu/en/humanregulatory/marketing-authorisation/conditional-marketing-authorisation. Accessed 17 July 2022