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Regulatory: Page 29
Regulatory
The FDA Doesn’t Want you Diagnosing Concussions with an App
The FDA is warning the public against using medical devices marketed to help assess, diagnose, or manage head injuries.
April 18, 2019
Pharmaceuticals
Cancer Vaccine Shows Promise in Clinical Trial
The experimental cancer vaccine teaches the cancer patient’s body to recognize tumors and attack them.
April 16, 2019
Regulatory
Sharp Receives MHRA Approval for Clinical Services Centre of Excellence
The site enables Sharp to offer a broader range of integrated services including serialization and Interactive Response Technology (IRT) solutions for clinical trial management.
April 16, 2019
Traceability/Serialization
Cartons and Bottles Most Serialized Package Types
Part Three of a Special Report illustrates the range of package formats involved in corporate serialization efforts.
April 9, 2019
Traceability/Serialization
Antares Vision: Verification Router Service System for DSCSA Compliance
AVrs is designed to offer efficient data management and compatibility with external software and hardware.
April 8, 2019
Traceability/Serialization
TEKLYNX: Enterprise Labeling
TEKLYNX CENTRAL CFR 5.0 and TEKLYNX CENTRAL GHS 5.0 offer companies in medical device, pharmaceutical, life sciences and chemical manufacturing a centralized system for label design, security and traceability, print automation and regulatory compliance.
April 3, 2019
Traceability/Serialization
Live from Interphex: The Human Challenge in Manual Aggregation
Six months after the serialization enforcement date, a new challenge emerges. Staff and processes must be set up to keep rejected product… rejected.
April 2, 2019
Traceability/Serialization
Nephron Pharmaceuticals Implements Kit Check for Serialization of Prefilled Syringes
Radio-Frequency Identification (RFID) tags are embedded on all prefilled syringe products at the Nephron 503B Outsourcing Facility.
April 1, 2019
Regulatory
Schreiner MediPharm and Edelmann Group: Smart Packaging System Demo
The smart packaging system demo developed by Schreiner MediPharm jointly with the Edelmann Group includes digital and analog technologies for product authentication and tamper evidence.
April 1, 2019
Pharmaceuticals
DSCSA Focus Shifts to Wholesaler/Distributors
Healthcare Packaging looks at the Drug Supply Chain Security Act (DSCSA), circa 2019, in this exclusive interview with Peter Sturtevant, Senior Director, Industry Engagement—Pharmaceuticals, GS1 US.
March 27, 2019
Traceability/Serialization
Kezzler Announces Six Billion Products with Unique Digital Identities in 2019
Kezzler’s campaign records half a million consumer interactions daily, peaking above 1,800 API calls per minute.
March 26, 2019
Traceability/Serialization
Serialization Responsibilities Spread Across a Diversity of Job Functions
Part Two of a Special Report on serialization demonstrates the wide range of job duties tasked with the responsibility of meeting this mandate.
March 22, 2019
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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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