Table 2.
List of abbreviations.
| BPCA | Best Pharmaceuticals for Children Act |
| CDER | Center for Drug Evaluation and Research |
| CHMP | Committee for Human Medicinal Products |
| EMA | European Medicines Agency |
| FDA | Food and Drug Administration |
| FDASIA | FDA Safety and Innovation Act |
| iPSP | initial Pediatric Study Plan |
| PDCO | Paediatric Committee |
| PeRC | Pediatric Review Committee |
| PIP | Paediatric investigation plan |
| PMDA | Pharmaceuticals and Medical Devices Agency |
| PPSR | Proposed Pediatric Study Request |
| PREA | Pharmaceutical Research Equity Act |
| PRIME | Priority medicines |
| PSP | Pediatric study plan |
| SAWP | Scientific Advice Working Party |
| TGA | Therapeutic Goods Administration |
| T2DM | Type 2 diabetes mellitus |