Pediatric Rule of 1994

FDA must conclude that the course of the disease and the effects of the drug, both beneficial and adverse, are sufficiently similar in the pediatric and adult populations to permit extrapolation of adult efficacy data to pediatric patients.

FDA must conclude that the course of the disease and the effects of the drug, both beneficial and adverse, are sufficiently similar in the pediatric and adult populations to permit extrapolation of adult efficacy data to pediatric patients.