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Leaders (UNIVERSAL TAXONOMY HCP): Page 293
Pharmaceuticals
What’s a regulatory crime?
Violations of the FDA’s requirements can put you in jail for a misdemeanor even if you didn’t intend to commit them.
September 21, 2015
Pharmaceuticals
Regulations, ‘silos’ slow pharmaceutical serialization progress
In this opinion piece, Healthcare Packaging Publisher Jim Chrzan suggests focusing on change management, looking outside pharma, and questions the promise of global harmonization.
September 18, 2015
Medical Device/Packaging
Couple sold unapproved medical devices to cancer, AIDS patients
One of them also admitted to intending to defraud and mislead the FDA.
September 16, 2015
Medical Device/Packaging
3-D printing helps get medical devices to war-torn areas
The project's founder hopes to help combat the shortage of medical supplies in the Gaza Strip.
September 16, 2015
Materials
Contract packager unveils technology for meeting serialization requirements
PCI’s ‘FlexLine’ standalone service compliments a company’s integrated serialization technologies.
September 16, 2015
Medical Device/Packaging
Collaborative robots help double output
Faced with rising production costs and lower price demands from customers, Tegra Medical, a contract manufacturer of medical devices, automated key aspects of its production operations with small, collaborative robots.
September 15, 2015
Packaging/Filling
Edson Packaging Machinery: Case packer
The Raptor SL erects, packs, and seals up to 12 cases/min.
September 15, 2015
Supply Chain
Crowdfunding creates unique challenges for medical device makers
There is a lot of grey area when it comes to devices that can be bought before getting FDA approval.
September 13, 2015
Medical Device/Packaging
3-D printed rib reduces risk for cancer patient
The first-of-its-kind medical device prevents some of the complications associated with the typical treatment.
September 13, 2015
Materials
Rollprint Packaging Products: Easy-open Barex replacement
Peelable Barex® replacement structure targets pharmaceutical and combination drug single-dose applications.
September 11, 2015
Medical Device/Packaging
FDA releases Medical Device Single Audit Program status report
The pilot program's objectives include developing the infrastructure, processes, training, and stakeholder commitment necessary to launch the operational phase.
September 11, 2015
Medical Device/Packaging
OpenFDA expands medical device data access
The agency hopes the move will spark innovation.
September 9, 2015
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