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Regulatory: Page 36
Pharmaceuticals
Pharmaceutical Packaging Serialization Lagging as DSCSA Enforcement Deadline Looms
Assessments by AmerisourceBergen, Cardinal Health, and McKesson Pharmaceutical shows nearly 80% of packages do not meet requirements.
October 18, 2018
Regulatory
Electronic ‘Smart’ Label for Clinical Trials
CCL's new label platform uses smartphone technology to improve medication adherence by engaging patients, clinicians and health organizations.
October 15, 2018
Pharmaceuticals
Pineberry Partners on Pharmaceutical Serialization, Aggregation
Company displays its CartonTrac FC (Flat Carton) serialization system that’s incorporated with Adents’ Pharma Suite serialization software.
October 14, 2018
Packaging/Filling
ESS Technologies, Antares Vision Show Serialized Case Packing System
Companies collaborate on robotic case packaging and serialization system that’s on display and operating at Booth S-3760 during PACK EXPO International.
October 14, 2018
Traceability/Serialization
Grandfathered Products? Keep Your Records!
How will trading partners know which products are grandfathered after Nov. 27?
October 8, 2018
Traceability/Serialization
ICYMI: FDA Released Three DSCSA-Related Guidances
New draft and finalized guidance docs were recently released regarding product identifiers and grandfathering.
October 4, 2018
Pharmaceuticals
FDA’s Late Recommendation on Human-Readable Format
What makes this new draft guidance frustrating is that it was published after drug manufacturers have finished configuring, testing, deploying and validating their serialization solutions in advance of the November deadline.
October 3, 2018
Packaging/Filling
Marchesini: Track Pack Equipment
Track Pack combines the BL A415 labeler and the PS 300 case packer in a compact machine that’s just 3.5 meters long x 2.3 meters wide.
October 1, 2018
Regulatory
FDA Modernizes its Approach to Clinical Trials for Drugs and Biologics
Agency issues two new draft guidances in an effort to make clinical trials more efficient while lowering costs and strengthening its ‘gold standard for safety and efficacy.’
September 28, 2018
Pharmaceuticals
Aggregation System Creates Parent-Child Relationship
Pharmaceutical firm employs supply chain serialization/aggregation with automated product track-and-trace abilities.
September 26, 2018
Supply Chain
FDA Takes Renewed Aim at E-Cig Marketing
Some brand owners who received warning letters have 60 days to come up with plans to address teen use of their products. Distribution is also under the microscope.
September 19, 2018
Pharmaceuticals
OxyContin Creator Sued for Creating Opioid Epidemic
Colorado’s attorney general is suing Purdue Pharma for its “significant role in causing the opioid epidemic.”
September 17, 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.
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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
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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Induction Sealing Gap System
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