Pediatric Investigation Plans: Part 1 – Determining Taste Masking Challenge
Regulations in the EU and US require the development of pediatric dosage forms of every new drug. Pediatric Investigation Plans (for EMA) and Pediatric Study Plans (for FDA) should be submitted early in development, but frequently are filed late and lack specificity. A savvy applicant should take a proactive approach by proposing scientific, stage-gate study plans to fulfill regulatory requirements while mitigating technical and economic risks.