This episode provides a comprehensive overview of the major guidelines from the FDA (Food and Drug Administration) and the ICH (International Council for Harmonization) that shape drug development. The primary focus is on understanding the core principles of safety and quality, and how these are practically implemented in research and development (R&D). This episode covers relevant sections of 12CFR and ICH modules to explore specific requirements. The episode is design to demystify complex regulations.

We'll delve into critical regulatory documents and their practical impact, illustrating how these guidelines influence every stage of a drug's lifecycle, from initial discovery to manufacturing. We'll also examine the FDA's role, including meetings, audits, and applications, to highlight their oversight throughout the process. International harmonization efforts are discussed to touch upon their aim to streamline the drug development across various countries.