Opening the FDA’s History Vault
Monthly video series highlights the agency’s run-ins with questionable products through the decades
Tougher Quality Management Enforcement Possible by FDA
New regulations on combination products, and an unknown future as new chair appointment still pending
Key Challenges for Risk Management in Medical Device Development
A proactive approach in a high-risk sector
Combination Products Review Program
Progress and potential report
The FDA Mutual Reliance Initiative
A new path for pharmaceutical inspections in Europe and beyond
Risk Management Programs: What the Latest Wave of HIPAA Fines Means
It was a busy year for Health and Human Services
FDA Warning Letters Target Weak CAPA Programs Globally
What to know—and avoid
Creating a Safety Net for Medical Devices
A life-cycle approach for monitoring cybersecurity vulnerabilities
How Strong Is Your QMS Program?
New international Meddev rules challenge complacent organizations
Manage Your Risk When Choosing Healthcare Payment Models
One size does not fit all
RAPS Review: FDA CDRH Director Shuren Talks Priorities
The agency’s 2017 goals featured at regulatory professionals conference
Registration of Food Facilities
A key link in the safety chain
Eight Reasons Why Your Design Controls and Risk Management Processes Fail
Embrace the total product life cycle
The FDA Forms New Partnerships to Ensure Product Safety
Creating global alliances to meet the challenge
What We Mean When We Talk About EvGen, Part 2
Building out a national system for evidence generation
When Chemistry Meets Marketing
The curious logic behind prescription drug names
Passing an FDA Quality System Inspection
Understand the importance of three overlooked parts: 820, 803, and 806
What We Mean When We Talk About EvGen, Part 1
Laying the foundation for a national system for clinical evidence generation
Amping Antimicrobial Discovery With Automation
Robots lighten the laboratory load
The Center for Biologics Evaluation Keeps Biological Product Standards High
A laboratory quality management system is key