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Regulatory: Page 20
Regulatory
Fresenius Kabi Goes Above and Beyond DSCSA Requirements
With the support and standards of GS1 US, the pharmaceutical manufacturer fulfills customer needs for an additional system to ensure safe use of medication on a unit-of-use level.
August 12, 2021
Medical Device/Packaging
Manufacturers To Highlight Medaccred Accreditation At Medical Design And Manufacturing (West) 2021
August 11, 2021
Regulatory
FDA Final Guidance: Form and Content of the Unique Device Identifier (UDI)
FDA
The document is intended to assist labelers and FDA-accredited issuing agencies in complying with unique device identifier (UDI) labeling requirements, including by clarifying FDA’s interpretation of certain requirements under 21 CFR 801.40.
July 10, 2021
Regulatory
Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages
FDA
Guidance for industry and FDA staff. Comments can be submitted.
May 21, 2021
Traceability/Serialization
Pharma Supply Chain: Master Data Exchange in 2021
The exchange of data needs to move from today’s manual processes to automated operations. Experts recap current progress, challenges, and what a “happy path” looks like.
May 20, 2021
Cannabis
One Step Closer to Cannabis Access for Medical Research
After years of dragging their heels on approving marijuana cultivation applications for research, the DEA looks to be moving forward with licenses soon.
May 18, 2021
Cannabis
Smudge-Proof Cannabis Batch Labels Offer Colorful Compliance
High Desert Pure employs on-demand printing for up-to-the-minute compliance and traceability information for its nearly 30 SKUs.
May 6, 2021
Inspection
Expedite Med Device Approval with FDA’s New Program
Medical device manufacturers can potentially speed review by testing to recognized standards performed at a list of FDA-accredited labs released in April 2021. Watch this Take Five video to learn more.
April 30, 2021
Packaging/Filling
2021 PDA Annual Meeting: Trend Roundup
The Parenteral Drug Association (PDA) virtual conference offered plenty of new perspectives in aseptic filling, flexible facilities, and more.
April 28, 2021
Materials
ASTM International Honors PAXXUS CEO with Award of Merit
PAXXUS
Dhuanne Dodrill, CEO of PAXXUS, has been honored by ASTM International for her efforts in medical packaging.
April 19, 2021
Regulatory
Pre-Fabricated POD for Filling? Don’t Overlook One Key Topic | Modular: The Modern Way of Manufacturing Injectables
If you’re implementing a pre-fabricated POD at your facility, this Take Five video answers why you can’t overlook space for support systems. Also covered: As injectables increase, they become more customized, requiring modular, future-proof equipment.
April 16, 2021
Podcasts
CANnabis or CAN’Tabis: Where is Cannabis Heading Amid New Administration?
Listen in as Healthcare Packaging's director of editorial content talks new directions for cannabis regulation, packaging updates, consumer behavior, and more.
April 6, 2021
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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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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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