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11 In 2021, EMA and FDA published a common commentary on pediatric oncology drug development, which lays out common issues requested for discussions by both agencies so that sponsors have an opportunity to address key issues early on and enable simultaneous submission of paediatric investigation plans (PIPs) to EMA and initial pediatric study plans (iPSPs) to FDA (FDA and EMA, 2021)

Patients with a personal or family history of MTC or MEN2 should not receive these medications

IP position

The dominant narrative won

It offers broader metabolic effects

Most studies were conducted in Europe and Asia, and most reported outcomes after 6 months of treatment