ADME	Absorption, distribution, metabolism, and excretion
ANDA	Abbreviated new drug application
API	Active pharmaceutical ingredient
BLA	Biologics license application
BPCA	Best Pharmaceuticals for Children Act of 2002
CGMP	Current Good Manufacturing Practice
CINV-MEC	Chemotherapy-induced nausea and vomiting
CRL	Complete response letter
DQSA	Drug Quality and Security Act of 2013
FDAMA	Food and Drug Administration Modernization Act of 1998
IND	Investigational new drug
NCE	New chemical entity
NDA	New drug application
NICHD	National Institute for Child Health and Human Development
NME	New molecular entity
PK	Pharmacokinetic
PREA	Pediatric Research Equity Act of 2003
PRV	Rare Pediatric Disease Priority Review Voucher Program of 2012
PSP	Pediatric study plan
RCT	Randomized clinical trial
sNDA	Supplementary NDA
US-FDA	United States Food and Drug Administration