Regulations.gov document: Reference 15 - U.S. Food and Drug Administration. S5(R3) Detection of Reproductive and Developmental Toxicity for Human
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/s5r3-detection-reproductive-anddevelopmental-toxicity-human-pharmaceuticals
Regulations.gov document: Reference 15 - U.S. Food and Drug Administration. S5(R3) Detection of Reproductive and Developmental Toxicity for Human
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/s5r3-detection-reproductive-anddevelopmental-toxicity-human-pharmaceuticals — retained record — High Signal