ARTICLES BY KATIE ANDERSON
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Makary's Exit Raises New Questions About FDA Stability And Direction5/13/2026
After serving as Commissioner of the U.S. Food and Drug Administration for a little over a year, Dr. Marty Makary resigned on May 12, 2026.
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[Video] Get It Right with The Gemba5/8/2026
The idea of the Gemba walk originated after World War II in Japan, specifically in relation to automotive production at Toyota. The word can be translated to “the real or actual place,” referring to where the work takes place—in the case of pharma or automobiles, on the factory floor.
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Making Mental Health Drugs: Promising Therapies And Manufacturing Challenges4/30/2026
Psychedelic therapies have shown promise in treating mental health disorders, but it will take close collaboration and cooperation of all related agencies and manufacturers to make this promise a reality.
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A 5-Step Foundation For Early CQV Involvement4/28/2026
All too often, a project’s issues show up in CQV, and it is there that blame is pointed. However, these issues start earlier and are entirely avoidable with proper planning.
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Challenges And Solutions In Aseptic Evolution4/22/2026
Aseptic processing has undergone a considerable evolution over the past 35 years in new equipment, standards, procedures, training and regulation. Navigating these challenges is essential to minimizing risk.
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ISPE Announces 2026 FOYA Winners4/20/2026
These awards recognize pharmaceutical and biopharmaceutical manufacturing projects that demonstrate excellence across innovation, operations, supply chain, Pharma 4.0, and social impact.
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6 Things You Need to Know from Life Sciences Future SW4/16/2026
For momentum in pharmaceutical research and development, consider taking a second look at Western Pennsylvania, where capital is flowing in, innovation is picking up and growth is expected.
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Lilly's Toolbox For Fast Track Fill Finish Sites4/1/2026
Constructing greenfield fill finish sites is always a complex task, but throw in there the added challenge of delivering the site expediently, and the task becomes increasingly complicated.
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4 Facility Considerations for API Manufacturing3/25/2026
Success depends not only on equipment and infrastructure, but also on specialized workforce training, rigorous quality control, robust data management, and increasingly sophisticated supply chain and manufacturing technologies.
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Raising The Bar In Radiopharmaceutical Manufacturing3/12/2026
Ratio Therapeutics chief commercial and manufacturing officer, Scott Holbrook, joined me to discuss how his team at Ratio Therapeutics is tackling the challenges of radiopharmaceutical manufacturing.