How are New Small Molecule Drugs Developed for Pediatric Use?
The development of new small molecule drugs for pediatric use involves several stages, including preclinical research, clinical trials, and regulatory approval. Given the ethical considerations, pediatric clinical trials often follow strict guidelines to protect young participants. Regulatory agencies like the FDA and EMA have specific pathways to encourage the development of pediatric medications, such as the Pediatric Research Equity Act (PREA) and the Pediatric Investigation Plan (PIP).
