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‘Gluten-Free Water’ Shows Absurdity of Trend in Labeling What’s Absent
Consumers will become ever-more mystified about what’s on a label
Three Stages of Quality Management System Implementation and Oversight
The most important lessons I’ve learned in pharmaceutical quality assurance during the last 40 years
Inside Quality Digest Live for Oct. 27, 2017
Cost-cutting at Ford, compassionate-use drugs, and innovation stagnation
FDA Eases Application Process for Compassionate Use
FDA recognizes that time is critical for seriously ill patients who do not have alternative therapies
Inside Quality Digest Live for October 20, 2017
All technology, all the time
Design Validation vs. Clinical Evaluation
What’s the difference?
Are Your Medical Devices Secure?
Physical well-being and confidentiality depend on it
FDA Seeks Public Input on Modernizing Regulatory Framework
Public dockets will solicit feedback from patients, consumers, health providers, and state governments
Leveraging FDA Resources to Encourage Students to Pursue STEM Careers
In oncology drug development, government, regulatory medicine, and cancer advocacy
Inside Quality Digest Live for August 11, 2017
Self-climbing stairs, after-sales service, and can you be too concerned about quality?
Medical Device Manufacturers Warned for CAPA Noncompliance
FDA warning letters indicate the agency continues to be concerned about noncompliance
Fostering Medical Innovation
A plan for digital health devices
The Sugary Drink Tax
How to keep your profits from going flat
How Will Real-World Evidence Affect 2017 FDA Guidances?
Medical device manufacturers want clarity
Quality Management Insights for Medical Device Manufacturers
CDRH is walking the talk and expects device manufacturers to do the same
Solving Compliance and International Manufacturing Challenges
Zimmer Biomet uses PULSE and SmartQuality solutions for FDA compliance and continuous improvement
Data-Driven Medicine
Five promising trends toward improving patient care
PRISM Identifies Vaccine Safety Issues
Making sense of vast streams of healthcare data
FDA: Helping Small Businesses Get Big Results
Small companies have a significant effect on U.S.-made pharmaceuticals
Five Tips for Medical Device Engineers on FDA Design Controls
Valid advice for every manufacturing vertical, too

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