Definition:

The FDA may grant a waiver from PREA (Paediatric Research Equity Act) requirements to study a medicine in children when: 

  • necessary studies are impossible or highly impracticable;  
  • there is evidence strongly suggesting that the product would be ineffective or unsafe in all paediatric age groups; or  
  • the product does not represent a meaningful therapeutic benefit over existing therapies.
More information:

Adult-related conditions that qualify for a waiver because they rarely or never occur in pediatrics (FDA)

Tags:
Definition, Encyclopaedia, Phase 1, Phase 2, Phase 3, Phase 4