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Canada's MDSAP Mandate Could Be Bad for Canadian Healthcare
By scaring off small medical-device companies, Canada could limit number of important and innovative products
Quality’s Role in Biomedical Morals and Ethics
For answers to some troubling life-science questions, ask a quality professional
Life Science Pioneer Takes Cues From 21 CFR and ISO 13485
Finch Therapeutics forges a QMS for a life-saving treatment not yet approved by the FDA
Top Five Things Life Science Companies Need to Know about ISO and FDA Requirements
Compliance, quality, and serving the patient
Occupational Health and Safety: A Standard Approach
ISO 45001 marks a significant step in the overall effort to improve OH&S standards worldwide
FDA Advances Efficient Approaches to Designing and Conducting Cancer Clinical Trials
Regulatory work must keep pace with emerging cancer therapies
Inside Quality Digest Live for August 10, 2018
Understanding cultural issues that help or hurt organizational performance
The American Chamber of Horrors
How a public exhibit led to the 1938 Food, Drug, and Cosmetic Act
Three Things Medical Marijuana Startups Need to Thrive Despite Regulatory Uncertainty
Building a foundation for FDA compliance
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

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