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Regulatory: Page 6
Regulatory
Inmar and Premier Deepen Partnership to Accelerate Pharmacy Reconciliation and Secure DSCSA Compliance
Inmar Intelligence
The collaboration includes a multi-year agreement for pharmacy claims reconciliation and a three-year renewal of Premier’s access to Inmar’s DSCSA compliance platform, which adds expanded functionality and broader trade class coverage.
September 24, 2025
Podcasts
Through the Line
Podcast: Challenges in Medical Device UDI Implementation
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.
September 19, 2025
Supply Chain
FDA Launches PreCheck to Accelerate Domestic Drug Facility Approvals
The two-phase program is designed to expedite the approval of new pharmaceutical manufacturing facilities in the U.S. by providing enhanced regulatory guidance and communication to manufacturers.
September 17, 2025
Podcasts
Through the Line
Podcast: Improving DSCSA Data Exchange Accuracy
Based on an HDA survey, distributor members reported receiving accurate data for over 93% of purchase order lines from manufacturers. However, challenges remain with incomplete data, delayed data delivery, and difficult troubleshooting of barcodes and labels.
September 12, 2025
Regulatory
FDA's Phased Exemptions Aim to Smooth Supply Chain Compliance
The FDA's phased exemptions for manufacturers, distributors, and dispensers aim to address data exchange issues. But the industry is said to be ready.
September 3, 2025
Podcasts
Through the Line
Podcast: Tariffs Affect on the Healthcare Packaging Supply Chain
To avoid paying high tariffs, companies may implement strategies like inventory buffering, supplier diversification, and scenario planning to build resilience.
July 25, 2025
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
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
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
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
Regulatory
RegASK
June 20, 2025
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Top Stories
Medical Device/Packaging
When Worst Case Becomes Real: ISO 11607 and the Risk of Packaging Failure
Manufacturers who treat ISO 11607's worst-case clauses as a risk-management tool, rather than a box to check, are far better positioned to keep their packaging, and their products, performing as intended.
Pharmaceuticals
Are Bacteria Cellulose Face Masks the Future of Skin Health?
Packaging/Filling
How an Integrated Leaflet Simplifies Pharmaceutical Cartoning
Package Design
What Autonomous Supply Rooms Mean for Healthcare Packaging
Package Development
Designing the Convenience of Tamper Evidence
Products
AI-enabled X-ray Inspection Software Platform
At PACK EXPO, Eagle launches SimulTask 6, which offers food processors advanced image analysis, real-time production monitoring, automated reporting, and task-based inspection.
Integrated Water Insoluble Matter Testing Systems
Induction Sealing Gap System
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Robotics/Automation
Market Snapshot: Life Sciences Manufacturing
Robotics/Automation
Automation Success on the Line
Labeling/Printing
Beyond the Label: Rethinking Healthcare Packaging
Package Design
Package Design Ideas Transforming Wellness, OTC, and Healthcare Brands
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