Regulatory: Page 55

Pharmaceuticals
FDA Issues One-Year Delay in DSCSA Product Identifier Enforcement
DSCSA law does not change, but enforcement is pushed back to Nov. 26, 2018, says agency in June 30 draft guidance.
July 5, 2017
This photo shows Adents' serialized cartons.
Traceability/Serialization
What’s the Biggest Serialization Hurdle?
New research from SEA Vision and Zenith Technologies points to technology selection as a major challenge, with many others not far behind.
July 5, 2017
What’s the Biggest Serialization Hurdle?
Cannabis
Revamped Medical Marijuana Effort at the Federal Level?
Though many states have legalized medical marijuana, it’s still technically prohibited by the federal government. The CARERS Act for compassionate access and research has been reintroduced by a bipartisan group of senators, hoping to lift the federal ban in states with medical marijuana programs.
July 3, 2017
Revamped Medical Marijuana Effort at the Federal Level?
Materials
Lisbon Summit Advances Serialization Supply Chain
Event helps forge partnerships as U.S. and European pharmaceutical CMOs, CPOs and 3PLs share strategies for serialization compliance and optimize post-implementation operations.
June 30, 2017
Lisbon Summit Advances Serialization Supply Chain
Inspection
Global Control Preferences Color New Serialization/Aggregation Lines
OEM APPLICATION NOTE: MGS focuses on small-footprint machinery that interconnects to other equipment on pharmaceutical lines and allows a single point of functionality.
June 27, 2017
MGS’s PV-600 carton inspection machine
Robotics/Automation
TraceLink: Software for EU FMD Requirements
Company unveils a mobile and web-based integrated compliance and digital information platform for pharmacies.
June 20, 2017
TraceLink: Software for EU FMD Requirements
Materials
Serialization Established for European Pharmaceutical CMO
Company implements serialization/aggregation on seven packaging lines at four sites in France to address requirements in multiple countries.
June 19, 2017
Serialization Established for European Pharmaceutical CMO
Regulatory
Opioid Epidemic: FDA to Hold Public Meeting
Certain drug formulations may deter abuse, such as those that make crushing or liquefying for injection more difficult. FDA is seeking public comment to evaluate whether these methods will have their intended impact in the real world.
June 16, 2017
Opioid Epidemic: FDA to Hold Public Meeting
Packaging/Filling
Apace Accelerates Track-and-Trace Operations
New solid-dose bottling line increases capacity, reduces labor costs and achieves Level 4 serialization and Level 3 aggregation.
June 13, 2017
Apace's new solid-dose bottling line.
Pharmaceuticals
Schreiner MediPharm: Clinical Trial Label Concept
Flexi-Cap combines first-opening indication and binding; combines anti-counterfeit protection and space for multilingual product information.
June 8, 2017
Schreiner MediPharm: Clinical Trial Label Concept
Pharmaceuticals
Antares Vision: Quick Compliance Program
Through a large stock of ready-to-go modules, this program enables serialization within 10 weeks.
June 7, 2017
Antares Vision: Quick Compliance Program
Regulatory
FDA: Delayed UDI Compliance Dates for Class I and Unclassified Devices
For lower risk devices, new compliance dates will extend into 2020 and 2022.
June 6, 2017
FDA: Delayed UDI Compliance Date for Class I and Unclassified Devices
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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.
Researcher in lab coat examining mannequin head with blue eye patches during cosmetic or skincare product testing
Pharmaceuticals
Are Bacteria Cellulose Face Masks the Future of Skin Health?
Technician in hairnet and blue shirt working at industrial machinery in laboratory setting
Packaging/Filling
How an Integrated Leaflet Simplifies Pharmaceutical Cartoning
Worker holding tablet displaying supply room inventory dashboard with charts in front of blue storage bins
Package Design
What Autonomous Supply Rooms Mean for Healthcare Packaging
3D printer setup with supply bottles and industrial equipment on red platform
Package Development
Designing the Convenience of Tamper Evidence
Products
Cagic industrial sorting and processing machine with control panel and conveyor system
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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Laboratory technician in sterile protective gear holding a clear glass vial for sample analysis
Robotics/Automation
Market Snapshot: Life Sciences Manufacturing
Pharmaceutical manufacturing assembly line with blue and white vaccine storage boxes and vials on conveyor system
Robotics/Automation
Automation Success on the Line
Healthcare professionals discussing pharmaceutical technology with medical storage equipment and digital analytics interface displayed
Labeling/Printing
Beyond the Label: Rethinking Healthcare Packaging
Elderberry & Honey Tonic bottle surrounded by dried flowers in white bowl on grass
Package Design
Package Design Ideas Transforming Wellness, OTC, and Healthcare Brands
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