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Regulatory

Medical Devices
What Is The Goal of the GS1 US Barcode Assessment?
The Barcode Assessment revealed that while most manufacturers are now labeling medical devices with barcodes containing the mandated Unique Device Identifier (UDI), healthcare providers aren’t consistently scanning those barcodes at the point of care.
July 9, 2025
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Regulatory
Study Reveals the U.S. Pharmaceutical Firms with the Most FDA Recalls
An AI healthcare platform analyzed 13 years of FDA data to identify companies with highest recall rates and most dangerous violations.
July 7, 2025
Medidex, an AI-powered medical chatbot platform, analyzed every pharmaceutical recall from 2012 through 2024, looking at both how often companies recalled products and how dangerous those recalls were.
Regulatory
Bridging the Barcode Divide: Challenges in Medical Device UDI Implementation
GS1 US Barcode Assessment reveals that full UDI implementation is often impeded at the provider level.
July 2, 2025
The Barcode Assessment revealed that while most manufacturers are now labeling medical devices with barcodes containing the mandated UDI, healthcare providers aren’t consistently scanning those barcodes at the point of care.
Regulatory
Community Poll: Benefits of AI in Healthcare Packaging
Learn where your peers stand on the advantages of AI in healthcare packaging.
June 23, 2025
Regulatory
How AI Will Help Brands Transform Packaging Compliance and Speed to Market
RegASK’s AI tool uses machine learning, in partnership with Esko, to deliver clear, up-to-date regulatory information, helping brands keep up with changing rules in different markets.
June 23, 2025
To address the new and evolving regulations within the industry, and streamline packaging development, RegASK recently partnered with Esko, a global leader in integrated software and hardware solutions for packaging and labeling.
Regulatory
RegASK
June 20, 2025
Regulatory
Kala Shankle
June 9, 2025
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Traceability/Serialization
Column: Improving DSCSA Data Exchange Accuracy During the FDA’s Phased Exemption Periods
Healthcare Distribution Alliance (HDA)
As the first exemption period has come to an end, the Healthcare Distribution Alliance and its members, have seen significant improvements in trading partner serialized transaction data exchange.
June 9, 2025
For distributors, technical troubleshooting for inadequate bar codes and label quality remains challenging to resolve and onboarding new manufacturers can be difficult because it is time-consuming and highly technical.
Supply Chain
Shoring Up the Healthcare Packaging Supply Chain is a Lot Like Flying a Plane
Tariffs could be a hidden opportunity for packaging professionals to re-evaluate and diversify suppliers.
June 2, 2025
The experts agree that there is no time to waste the chance to re-evaluate your packaging supply chain, strengthen its resiliency, and mitigate the impact of potential tariffs.
Regulatory
Avoid FDA warning letters with expert compliance strategies
Discover industry-tested approaches to strengthen quality systems and navigate regulatory scrutiny in this comprehensive guide for manufacturing professionals.
May 21, 2025
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Regulatory
How to Answer an FDA Warning Letter
Today’s manufacturing and packaging experts offer a range of advice for how to proceed and what to avoid when warning letters are delivered.
March 14, 2025
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Supply Chain
Phased DSCSA Implementation: A Discussion with Industry Experts
A recent webinar in the HDA’s Traceability Webinar series looked at the common question, ‘what if my supplier isn’t compliant?’
February 11, 2025
Phased DSCSA Implementation: A discussion with industry Experts
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Top Stories
Through the Line: Packaging and Processing
Adherence/Delivery
Through the Line: Addressing Medication Adherence
How can packaging simplify medication adherence? When enrolled in Amazon's PillPack, customers receive monthly shipments of daily tear-away packets that are personalized and labeled with each medication (and its dosage).
Every element of the package design, including the distinctive ampersand, was intentionally crafted to resonate with shoppers.
Package Design
McKesson’s New Consumer-Focused OTC Brand Includes an Aluminum Packaging Line
Medidex, an AI-powered medical chatbot platform, analyzed every pharmaceutical recall from 2012 through 2024, looking at both how often companies recalled products and how dangerous those recalls were.
Regulatory
Study Reveals the U.S. Pharmaceutical Firms with the Most FDA Recalls
Through the Line: Packaging and Processing
Package Design
Through the Line: At-home Test Kits
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Package Development
Packaging Recycling Professionals Gathered in Person and Remotely for this Year's Packaging Recycling Summit
List: Digitalization Companies From PACK EXPO
Looking for CPG-focused digital transformation solutions? Download our editor-curated list from PACK EXPO featuring top companies offering warehouse management, ERP, digital twin, and MES software with supply chain visibility and analytics capabilities—all tailored specifically for CPG operations.
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List: Digitalization Companies From PACK EXPO
Break out of the ordinary: see what’s new in life sciences packaging
<strong>At PACK EXPO Las Vegas, you’ll see machinery in action and new tech from 2,300 suppliers, collaborate with experts and explore transformative solutions. Join us in September to experience a breakthrough for life sciences products.</strong>
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Break out of the ordinary: see what’s new in life sciences packaging
Products
Esko
Packaging Artwork Platform
Esko WebCenter is a platform designed to digitize and automate packaging workflows while maintaining regulatory compliance and traceability.
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Leak Detection Equipment for Flexible Packaging
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Materials
Researched List: Mono-Material, Barrier Pouches
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Machinery
Cartoning Innovations Report
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Robotics/Automation
Robotics Innovations Report
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Regulatory
Avoid FDA warning letters with expert compliance strategies
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