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Regulatory: Page 9
Temp Control/Cold Chain
Top 10 of 2023 - #7: Merck Expert Shares 5 Tips for Qualifying Pallet-Sized Thermal Shippers
Join us as we look back at the most-read Healthcare Packaging stories of 2023. At #7, find out why Lee Menszak advocates for shipper-to-shipper variability testing from his talk at ISTA’s TempPack event.
December 27, 2023
Traceability/Serialization
Top 10 of 2023 - #9: Fresenius Kabi Infuses Safety with Unit-of-Use 2D Barcodes
Join us as we look back at the most-read Healthcare Packaging stories of 2023. At #9, the Germany-based company enhances efficiency and patient care through innovative labeling solutions.
December 23, 2023
Regulatory
Syntegon Podcast Covers Pharma Topics From a Machine-Builder Point of View
Syntegon
On Syntegon’s new podcast series “Machines & Medicine,” pharmaceutical manufacturing experts discuss complex issues in the industry, which faces regulations like no other.
December 14, 2023
Regulatory
Preparing For Your Next FDA Inspection
Your checklist to ensure a passing grade.
November 28, 2023
Regulatory
FDA Issues Draft Guidance for Biosimilar Products Labeling
The guidance explains what relevant data and information from the reference product labeling should be incorporated into biosimilar and interchangeable biosimilar product labeling.
November 10, 2023
Regulatory
State and Federal PFAS Regulations Tightening
Companies need to be mindful of both incoming PFAS regulations and how PFAS might be present in their operations to stay safe from legal trouble.
November 10, 2023
Traceability/Serialization
Op-ed: Collaboration Is Critical for DSCSA Stabilization
The FDA recently announced a DSCSA “stabilization policy,” but further clarity and education will be needed for all trading partners to ensure they reach compliance.
October 26, 2023
Regulatory
FDA Issues Drug Development Benefit-Risk Assessment Guidance Document
U.S. Food and Drug Administration
The agency has released its “Benefits-Risk Assessment for Human Drug and Biological Products” final guidance to provide a clearer understanding of the FDA's decision-making context and benefit-risk considerations in drug development.
October 23, 2023
Medical Device/Packaging
thePACKout 2024 Call for Abstracts is OPEN
October 6th is the last day to submit abstracts (submission site closes at 11:59 PM EST).
September 27, 2023
Adherence/Delivery
FDA Approves OTC Designation for Vonco’s Enteral Feeding Solution
Vonco Products, LLC
EnteraLoc Flow is the first seamless, closed-loop enteral feeding solution that combines a spill-proof pouch, direct-connect ENFit® device, tube, and nutritious food options in a single, complete feeding system.
September 26, 2023
Home
Shipping Label Software Offers Color Boost for Dynamic Content
Epson’s new Label Boost system creates colorful shipping labels for compliance, ads, and more.
September 23, 2023
Regulatory
FDA Issues Final Guidance for Use of ISO 10993-1 for Medical Devices
FDA
The document provides further clarification and updated information on the use of International Standard ISO 10993–1, “Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process.”
September 14, 2023
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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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