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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FDA Issues Draft Guidance on Labeling Rx and Biologics Products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
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
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
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
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
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
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
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
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
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
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
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
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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
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AI-enabled X-ray Inspection Software Platform
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Induction Sealing Gap System
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Robotics/Automation
Market Snapshot: Life Sciences Manufacturing
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Automation Success on the Line
Labeling/Printing
Beyond the Label: Rethinking Healthcare Packaging
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