Regulatory: Page 49

Pharmaceuticals
Nordic Group Takes on Large-Scale Serialization Program
European pharmaceutical company partners with Supply Chain Wizard to implement serialization across multiple lines to meet U.S. and EU regs.
December 12, 2017
Nordic Group Takes on Large-Scale Serialization Program
Regulatory
FDA Issues Promotional Labeling Guidance
Agency takes new steps to help ensure clear presentation of health information in prescription drug promotion in an ongoing effort to protect consumer health.
December 11, 2017
Regulatory
OPTEL Obtains End-to-End Traceability via Verify Brands
OPTEL GROUP has announced it is expanding its traceability offering through the acquisition of Verify Brand.​
December 7, 2017
OPTEL Obtains End-to-End Traceability via Verify Brands
Regulatory
Medi-Dose/EPS: Tamper-Evident Syringe Seal
Steri-Tamp Tamper-Clear Syringe Seal is designed to offer a tamper-evident seal with clear visibility of syringe graduations.
December 5, 2017
Steri-Tamp Tamper-Clear Syringe Seal is designed to offer a tamper-evident seal with clear visibility of syringe graduations.
Regulatory
FDA Updates 21st Century Cures Act Implementation
FDA Commissioner Scott Gottlieb provides testimony before the House Committee on Energy and Commerce on treatment advances and accelerated drug approvals.
November 30, 2017
Researchers at work in lab.
Labeling/Printing
Adents: Enhanced Carton Coding/Inspection System
Employs Omega Design’s Remote Integration Program to offer Intelli-Code for pharmaceutical market.
November 29, 2017
Adents: Enhanced Carton Coding/Inspection System
Pharmaceuticals
Recipharm Equips Three More Facilities for U.S. Serialization
With today’s DSCSA deadline, CDMO Recipharm now has nine locations able to supply serialized products to the U.S.
November 27, 2017
Labeling products on a Recipharm packaging line.
Regulatory
121nexus: App for GS1 and UDI Supply Chain Info
The Scanner App reads healthcare barcodes and offers device-specific information.
November 22, 2017
New App Launched for GS1 and UDI Supply Chain Info
Pharmaceuticals
FDA's Gottlieb on Promoting Generic Opioids to Curb Abuse
FDA Commissioner Scott Gottlieb released a statement outlining plans to reduce opioid addiction by limiting unnecessary exposure.
November 22, 2017
Dr. Scott Gottlieb, FDA Commissioner
Materials
FDA Addresses Opioids, Hurricane Relief, Regenerative Meds
Agency approves electric stimulation device to reduce opioid withdrawal symptoms, creates a policy regarding ‘paradigm-changing’ regenerative medicines, and addresses IV fluid shortages following hurricane destruction.
November 17, 2017
FDA Commissioner Scott Gottlieb, MD
Inspection
MG2: Pharma Line Serialization
Company completes line integration for a multinational company by supplying equipment for secondary packaging and a serialization system.
November 16, 2017
MG2's ACE CT/400 track-and-trace system.
Pharmaceuticals
FDA Approves First U.S. Drug with Digital Ingestion Tracking
Otsuka Pharmaceutical’s Abilify MyCite for schizophrenia includes an ingestible sensor embedded in the pill that sends a message to a patch worn by the patient, which transmits information to a mobile app, permitting smartphone tracking and communication.
November 14, 2017
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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
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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
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
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Package Design
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