References
- Shirkey H. Editorial comment: Therapeutic orphans. The Journal of
Pediatrics, 1968: 72(1): 119-120.
- Institute of Medicine. Safe and Effective Medicines for Children:
Pediatric Studies Conducted Under the Best Pharmaceuticals for
Children Act and the Pediatric Research Equity Act. Washington
DC: The National Academies Press.
https://doi.org/10.17226/13311; 2012.
- PREA. Pediatric Research Equity Act (PREA). Retrieved from
https://www.ncbi.nlm.nih.gov/books/NBK3997/
- BPCA. Best Pharmaceuticals for Children’s Act (BPCA). Retrieved from
https://bpca.nichd.nih.gov/Pages/default.aspx
- Yondelis. USPI. Retrieved from
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207953s005lbl.pdf
- Abraxane. USPI. Retrieved from
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021660s046lbl.pdf
- Jevtana. USPI. Retrieved from
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201023s023lbl.pdf
- Velcade. USPI. Retrieved from
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021602s044lbl.pdf
- Afinitor. USPI. Retrieved from
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022334s044,203985s016lbl.pdf
- Treanda. USPI. Retrieved from
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022249s024lbl.pdf
- Tasigna. USPI. Retrieved from
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022068s031lbl.pdf
- Taxotere. USPI. Retrieved from
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020449s083lbl.pdf
- Sutent. USPI. Retrieved from
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021938s036lbl.pdf
- Methotrexate. USP. Retrieved from
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011719s125lbl.pdf
- Xeloda. USPI. Retrieved from
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020896Orig1s042lbl.pdf
- Eloxatin. USPI. Retrieved from
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021759s023lbl.pdf
- Zometa. USPI. Retrieved from
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021223s041lbl.pdf
- phosphate. USPI. Retrieved from
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022137s003lbl.pdf
- Arimidex. USPI. Retrieved from
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020541s031lbl.pdf
- Camptosar. USPI. Retrieved from
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020571s051lbl.pdf
- Temodar. USPI. Retrieved from
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022277s013lbl.pdf
- Navelbine. USPI. Retrieved from
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020388s037lbl.pdf
- Gemzar. USPI. Retrieved from
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020509s082lbl.pdf
- Honig, S. 2002. Medical review for Navelbine (vinorelbine). NDA
20388/S014. Nov. 2002. Silver Spring, MD: Food and Drug
Administration.
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020388_S014_NAVELBINE_INJECTION
_AP.pdf (accessed April 3, 2012)
- Gemzar (gemcitabine HCL) pediatric written request. Jan. 2001. Silver
Spring, MD: Food and Drug Administration.
https://www.fda.gov/media/88726/download
- Pediatric Exclusivity Granted, Apr. 2016. Silver Spring, MD: Food and
Drug Administration. https://www.fda.gov/media/79154/download
- Shapiro, A. 2003. Medical review for Temodar (Teozolomide). NDA
21029/S005. Mar. 2003. Silver Spring, MD: Food and Drug
Administration. https://www.fda.gov/media/92216/download
- Ibrahim, A. 2003. Medical review for Camptosar (Irinotecan). NDA
20571/S021. Dec. 2003. Silver Spring, MD: Food and Drug
Administration.
https://www.fda.gov/files/drugs/published/N20-571S023-Irinotecan-Clinical-BPCA.pdf
- Vaidyanathan, J. 2008. Clinical pharmacology review for Anastrozole
(Arimidex). NDA22214. Feb. 2008. Silver Spring, MD: Food and Drug
Administration. https://www.fda.gov/media/75522/download
- Cohen, M. 2003. Medical review for Fludarabine Phosphate. NDA 20038.
July 2003. Silver Spring, MD: Food and Drug Administration.
https://www.fda.gov/files/drugs/published/N20-038S028-Fludarabine-Clinical-BPCA.pdf
- https://www.fda.gov/drugs/development-resources/approved-active-moieties-have-appeared-national-institutes-healths-nih-annual-priority-list-which
- Pediatric Exclusivity Determinations List. Silver Spring, MD: Food and
Drug Administration. https://www.fda.gov/media/132652/download
- Administrative and Correspondence document. NDA 205582.
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205582Orig1s000AdminCorres.pdf
- FDA written requests issued. Silver Spring, MD: Food and Drug
Administration.
https://www.fda.gov/drugs/development-resources/written-requests-issued
- RACE. Retrieved from
https://www.congress.gov/bill/114th-congress/senate-bill/3239
- Barone A, Casey D, McKee A, Reaman G. Cancer Drugs approved for use in
children: Impact of legislative initiatives and future opportunities.
Pediatric Blood and Cancer. 2019: 66(8): e27809
- Ye J, Reaman G, De Claro RA, Sridhara R. A Bayesian approach in design
and analysis of pediatric cancer clinical trials. Pharmaceutical
Statistics. 2020: doi.org/10.1002/pst.2039