The Food and Drug Administration (FDA), in collaboration with the European Medicines Agency (EMA), provided procedural assistance to sponsors and applicants who anticipate submission of paediatric product development plans for the treatment and prevention of COVID-19. In issuing this Common Commentary, the FDA and EMA aspire to streamline administrative processes and facilitate efficient submission of an initial Pediatric Study Plan (iPSP) and Paediatric Investigation Plan (PIP).
Given the need to generate clinical trial data to inform safe and effective use of products to treat and prevent COVID-19 in pediatric patients, FDA and EMA encourage early submission of an iPSP and PIP. Furthermore, FDA and EMA meet as needed to exchange information to facilitate product development for the pediatric population.
References to existing FDA and EMA guide on submission of an iPSP and PIP are provided in the document.