In oncology drug development, government, regulatory medicine, and cancer advocacy
Self-climbing stairs, after-sales service, and can you be too concerned about quality?
FDA warning letters indicate the agency continues to be concerned about noncompliance
A plan for digital health devices
How to keep your profits from going flat
Medical device manufacturers want clarity
CDRH is walking the talk and expects device manufacturers to do the same
Zimmer Biomet uses PULSE and SmartQuality solutions for FDA compliance and continuous improvement
Five promising trends toward improving patient care
Making sense of vast streams of healthcare data
Small companies have a significant effect on U.S.-made pharmaceuticals
Valid advice for every manufacturing vertical, too
Monthly video series highlights the agency’s run-ins with questionable products through the decades
New regulations on combination products, and an unknown future as new chair appointment still pending
A proactive approach in a high-risk sector
Progress and potential report
A new path for pharmaceutical inspections in Europe and beyond
It was a busy year for Health and Human Services
What to know—and avoid
A life-cycle approach for monitoring cybersecurity vulnerabilities