The FDA grants rare pediatric disease designation for diseases with serious or life- threatening conditions that affect people from birth to 18 years of age, that affect fewer than 200,000 people in the U.S.
View this resource Bookmark this resource
Rare Pediatric Disease Designation
Published by IRDiRC
Regulatory AffairsEarly Access SupportPaediatric MedicineOrphan Drug DesignationRare Paediatric Disease Designation