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Regulatory: Page 40

Regulatory
FDA Issues Draft Guidance on Labeling Rx and Biologics Products
Agency takes steps to encourage more informative labeling on prescription drug and biological products’ indications and usage.
July 6, 2018
FDA Issues Draft Guidance on Labeling Rx and Biologics Products
Pharmaceuticals
No Shortage of Creative Solutions
Drug shortages can have serious health effects, but early notifications from manufacturers and creative and flexible FDA actions are making a dent.
July 6, 2018
Eric F. Greenberg
Pharmaceuticals
Johnson & Johnson Supply Chain (JJSC) Employs Global Serialization Strategy
With a heritage of 130+ years of helping people live longer lives, JJSC’s serialization/traceability efforts focus on safely delivering medicines to healthcare providers and patients worldwide.
July 5, 2018
Carton serialization is part of J&J’s strategy to meet global regulatory demands.
Regulatory
Quality Issues Trigger Company Action, and Misty Columnist Memories
Two long-ago encounters about commitment to quality rattle around my brain, so I want them to rattle around yours, too.
July 3, 2018
Eric Greenberg
Traceability/Serialization
Report Projects Dynamic Track-and-Trace Market Growth
Should anyone think the serialization market might slow down once the Nov. 26, 2018 enforcement deadline to provide unit-level product identifiers on drug packages passes, it may be time to reconsider.
July 2, 2018
Report Projects Dynamic Track-and-Trace Market Growth
Pharmaceuticals
Adents: Verification Router Service
For pharmaceutical manufacturers and distributors, the VRS employs the company’s NovaTrack Blockchain benefits to address DSCSA requirements for sale of returned products.
June 28, 2018
Adents: Verification Router Service
Traceability/Serialization
Serialization Trends: 6 Mixed Emotions
From hospital traceability and blockchain use cases to Europe’s FMD readiness, speakers at the Adents Serialization Innovation Summit offered perspective on what’s happening now and what to “look forward” to.
June 26, 2018
Tianna Umann
Regulatory
Serialization a Key Focus in Developing Regions
Manufacturers face global challenges implementing serialization standards, according to a report by PMMI Business Intelligence.
June 22, 2018
Serialization a key focus in developing regions
Regulatory
When Drug Shortages Arise, FDA Helps Nudge Industry and Patients
The agency can, and does, do a lot of coaching from the sidelines when shortages occur
June 21, 2018
Eric Greenberg
Regulatory
Generic Drug Review Machinery Getting a Tune-Up
More generic drugs means more competition means lower prices and oh yeah, more packaging.
June 19, 2018
Eric Greenberg
Traceability/Serialization
Adents and Microsoft: End-To-End Traceability
NovaTrack utilizes blockchain, AI, internet of things and serialization functionalities that, when combined, bring visibility throughout product distribution chains & life cycles for performance and security but also governance and scalability.
June 14, 2018
NovaTrack utilizes blockchain, AI, internet of things and serialization functionalities that, when combined, bring visibility th
Pharmaceuticals
DSCSA Enforcement Readiness: Check
Pharmaceutical contract packager Reed-Lane works with consulting firm, machinery vendors on three key packaging lines to meet fast-approaching serialization enforcement deadline.
June 14, 2018
Inspecting data on printed labels for application to bottles.
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Top Stories
Sealed sterile syringe with needle in clear plastic packaging on dark background
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.
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Pharmaceuticals
Are Bacteria Cellulose Face Masks the Future of Skin Health?
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Packaging/Filling
How an Integrated Leaflet Simplifies Pharmaceutical Cartoning
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Package Design
What Autonomous Supply Rooms Mean for Healthcare Packaging
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Package Development
Designing the Convenience of Tamper Evidence
Products
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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.
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Robotics/Automation
Market Snapshot: Life Sciences Manufacturing
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Robotics/Automation
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