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FDA Proposes Process Modernization to Support New Drug Development
IT and collaboration key to efforts
Benefits of FDA’s Breakthrough Device Program
Fast-track program evaluates brain implants for the blind
How to Leverage an EQMS for Managing Product Adulteration
A document management system is now a compliance best practice
New Steps to Facilitate Medical Device Innovation
The least burdensome approach
FDA, International Regulators Look at Common Challenges to Innovation
More than 500 experts convene at summit in Kyoto, Japan
Inside Quality Digest Live for Nov. 10, 2017
Overcoming stress at work, the benefits of AS9100, and meaningless food labels
‘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

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