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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
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
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
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
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New eight-page draft guidance helps trading partners understand the process for requesting waivers, exceptions and exemptions from DSCSA product identifier requirements.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
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
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
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
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
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
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
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
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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
More Products
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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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