Regulations.gov document: Reference 16 - U.S. Food and Drug Administration. S11 Nonclinical Safety Testing in Support of Development of Pediatric
Pharmaceuticals: Guidance for Industry [Internet]. Silver Spring (MD): FDA; 2021 May [cited 2026 Aug 29]. Available
from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/s11-nonclinical-safety-testing-supportdevelopment-pediatric-pharmaceuticals — retained record — High Signal
Regulations.gov document: Reference 16 - U.S. Food and Drug Administration. S11 Nonclinical Safety Testing in Support of Development of Pediatric
Pharmaceuticals: Guidance for Industry [Internet]. Silver Spring (MD): FDA; 2021 May [cited 2026 Aug 29]. Available
from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/s11-nonclinical-safety-testing-supportdevelopment-pediatric-pharmaceuticals