Pharmacology
Phase 1 — Introduction to Pharmacological Research & Regulatory Framework
1.6 Regulatory Framework: Governing Bodies and Guidelines
1.6.5 US-FDA 21 CFR

1.6.5 US-FDA 21 CFR

Title 21 of the US Code of Federal Regulations governs pharmaceutical development in the United...

PharmacologyPhase 1 — Introduction to Pharmacological Research & Regulatory Framework1.6 Regulatory Framework: Governing Bodies and Guidelines1 min readUpdated 2026-07-13

Title 21 of the US Code of Federal Regulations governs pharmaceutical development in the United States. Part 58 defines Good Laboratory Practice requirements, Part 312 governs Investigational New Drug applications, and Part 314 governs New Drug Applications. All non-clinical safety data submitted to the FDA must be generated in compliance with Part 58 GLP.

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1.6.4 ICH S-Series and M3(R2)1.6.6 WHO and EMA