The Boiled Frog Phenomenon and the AI Generation
Data Integrity and Human Error
FDA Inspection Process: From Implementation to Completion
FDA Guidance Revision for Computer Systems Used in Clinical Investigations
The Origins of GMP (Good Manufacturing Practice)
The Historical Development of GMP Regulations and FDA Inspection Systems: Continuous Evolution in Protecting Patient Safety
Real-World Data: Pioneering New Frontiers in Pharmaceutical Development
The Establishment and Evolution of the United States Pharmacopeia: Building Trust in Medicine Quality