Business · 13/11/2017Updated: 10/17/2026 · 1 min read
FDA Releases Draft Guidance on Reproductive Toxicity for Human Pharmaceuticals
Summary
The FDA has made available a draft guidance document, S5(R3), which aims to harmonize reproductive toxicity testing for human pharmaceuticals, replacing the previous S5(R2 guidance and building on ICH guidelines.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →