Regulatory: Page 7

Traceability/Serialization
The Requirements of Pharmaceutical Packaging Compliance: System Integration, Investment, and Collaboration
In this Prominent People in Packaging interview, Aladin Alkhawam discusses the challenges and intricacies of implementing the Drug Supply Chain Security Act in the pharmaceutical packaging sector.
June 18, 2025
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Regulatory
Kala Shankle
June 9, 2025
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Traceability/Serialization
Column: Improving DSCSA Data Exchange Accuracy During the FDA’s Phased Exemption Periods
Healthcare Distribution Alliance (HDA)
As the first exemption period has come to an end, the Healthcare Distribution Alliance and its members, have seen significant improvements in trading partner serialized transaction data exchange.
June 9, 2025
Stacked product packaging with blue design and yellow barcodes
Supply Chain
Shoring Up the Healthcare Packaging Supply Chain is a Lot Like Flying a Plane
Tariffs could be a hidden opportunity for packaging professionals to re-evaluate and diversify suppliers.
June 2, 2025
The experts agree that there is no time to waste the chance to re-evaluate your packaging supply chain, strengthen its resiliency, and mitigate the impact of potential tariffs.
Podcasts
Through the Line Podcast: How to Respond to FDA Warning Letters
What should you do if your company receives a warning letter from the FDA? Manufacturing and packaging experts offer a range of advice for how to proceed and what to avoid when warning letters are delivered.
April 1, 2025
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Regulatory
How to Answer an FDA Warning Letter
Today’s manufacturing and packaging experts offer a range of advice for how to proceed and what to avoid when warning letters are delivered.
March 14, 2025
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Supply Chain
Phased DSCSA Implementation: A Discussion with Industry Experts
A recent webinar in the HDA’s Traceability Webinar series looked at the common question, ‘what if my supplier isn’t compliant?’
February 11, 2025
Phased DSCSA Implementation: A discussion with industry Experts
Regulatory
Appropriate Steps to Avoid And Answer FDA Warning Letters in 2025
The rate of warnings initiated by the FDA continues to rise in the pharma and medical device industries. Knowing how to best attempt to prevent them and respond to them can be equally important.
January 14, 2025
Fda 2
Regulatory
One-Minute Survey: Regulatory Compliance in Healthcare Packaging
What's on your mind? Please answer a few quick questions to tell us more about what you want to see in Healthcare Packaging.
December 3, 2024
Adherence/Delivery
FDA Warning Letters in Packaging: How Testing Can Help Prevent a 483
While testing doesn’t always prevent an FDA warning letter, doing so helps you stay in compliance and check the boxes the FDA is looking for.
October 23, 2024
Inadequate control and management of packaging materials is often cited. Most of the citations from these types of issues are focused on poor testing practices that don’t ensure the materials demonstrate they can adequately protect the product prior to its use.
Regulatory
California Restricts the Use of DEHP in IV Containers & Tubing
From January 1, 2030, the manufacture, sale, or distribution of intravenous fluid containers containing intentionally added DEHP will be prohibited within the state.
September 16, 2024
Roughly 90% of people that go into a hospital are going to end up having an IV bag and the numbers are round 70% of IV bags used in the U.S. are made from PV and DEHP.
Regulatory
The Impact of the Chevron Deference in Pharmaceutical Packaging
The Chevron Deference has recently been overturned, resulting in potentially less bureaucratic control over regulated industries, such as the FDA.
July 30, 2024
Patrick Gavit is a retired biochemist from Takeda Pharmaceutical Co., a Japanese multinational biopharmaceutical company.
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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.
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Pharmaceuticals
Are Bacteria Cellulose Face Masks the Future of Skin Health?
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Packaging/Filling
How an Integrated Leaflet Simplifies Pharmaceutical Cartoning
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Package Design
What Autonomous Supply Rooms Mean for Healthcare Packaging
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Package Development
Designing the Convenience of Tamper Evidence
Products
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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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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
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Labeling/Printing
Beyond the Label: Rethinking Healthcare Packaging
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Package Design
Package Design Ideas Transforming Wellness, OTC, and Healthcare Brands
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