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Regulatory: Page 42

Materials
Laws & Effect: Streamlining for Combination Products: Please, May I Have Some More?
Sure, FDA has proposed to help speed their reviews of new products that combine categories, but will it really get out of its own way?
May 16, 2018
Eric Greenberg
Pharmaceuticals
Barcode Integrity Crucial for Brand Authentication, Anti-Counterfeiting and Regulatory Compliance
Industry assessments are demonstrating that using verifiable, standards-based barcodes to improve traceability, block counterfeits and address regulation requirements will also enable operational, economic and patient safety improvements.
May 15, 2018
GS1 US current implementation chart.
Pharmaceuticals
FDA’s Gottlieb Comments on Trump Administration’s Plan to Lower Drug Prices
Commissioner Scott Gottlieb, MD, points to agency’s Drug Competition Action Plan and generic drug review process among its efforts ‘to put American patients first.’
May 11, 2018
FDA’s Gottlieb Comments on Trump Administration’s Plan to Lower Drug Pr
Traceability/Serialization
CPO Maintains Tailored Approach Adding Level 5 Serialization System
allpack offers customers greater flexibility and scale with a cloud-based system that maintains customer focus while managing and exchanging data for serialization compliance.
May 10, 2018
allpack
Traceability/Serialization
FDA: Guidance on DSCSA Waivers
New eight-page draft guidance helps trading partners understand the process for requesting waivers, exceptions and exemptions from DSCSA product identifier requirements.
May 9, 2018
DSCSA Waivers
Pharmaceuticals
Smart Pharmaceutical Packaging Demand Poised for Growth
The integration of NFC technologies into pharmaceutical applications, such as time-temperature indicator labels, is among the cutting-edge technologies Smithers Pira identifies as pushing brand owners toward intelligent packaging.
May 7, 2018
Smart Pharmaceutical Packaging Demand Poised for Growth
Regulatory
Laws & Effect: Weekly FDA Reports Bring Reminders of Packaging's Importance
If you get a look at FDA’s Enforcement Reports, don’t let the importance of packaging and labeling get lost in a fog of other details.
May 7, 2018
Eric Greenberg
Medical Device/Packaging
FDA Reclassifies Sharps Needle Destruction Device
Agency believes final order will decrease regulatory burden on manufacturers as they will no longer be required to submit a premarket approval application (PMA), but can instead submit a less-burdensome premarket notification (510(k)) before marketing this type of device
May 3, 2018
FDA’s Reclassifies Sharps Needle Destruction Device
Inspection
Porvair Filtration Group: Validation Services
For the company’s polymeric and disposable cartridge filters for use in multiple pharmaceutical manufacturing processes.
May 3, 2018
Porvair Filtration Group: Validation Services
Traceability/Serialization
Of Trees and Traceability
Intelligent supply chains have the potential to improve efficiency at the natural resource level and create opportunity for OEMs. Can people look beyond the next fiscal quarter?
May 2, 2018
scanning bags
Nutraceuticals/Dietary
Laws & Effect: Caffeine Cometh, But Not Always Safely
FDA’s action – well, guidance – about concentrated caffeine in dietary supplements shows that even common substances might not always be safe, but packaging might be a key solution.
May 1, 2018
Eric Greenberg
Regulatory
Data Integrity Code of Conduct
While the FDA asks pharma companies to heed its warnings around good manufacturing practices, the Parenteral Drug Association outlines actions to take.
April 27, 2018
Els Poff
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Top Stories
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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