Book 1A: 2026 Selected Regulations & Guidance for Drug Studies (With FDA/ICH GCP E6(R3))Description Contents Cover This spiral bound, 5" x 7. 5" book is a compilation of FDA regulations and guidance documents that govern the conduct of clinical trials for drug research and submission of applications to FDA for marketing approval (NDAs). It includes all of 21 CFR Part 314 on NDAs and the ICH GCP Guideline E6(R3). Who Uses this Book and How? Clinical Research staff, as job aids Training departments, as training handouts Human Resources, as