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Section: Industry News > Regulatory
Supply Chain
Through the Line Podcast: Tariffs Affect on the Healthcare Packaging Supply Chain
To avoid paying high tariffs, companies may implement strategies like inventory buffering, supplier diversification, and scenario planning to build resilience.
July 25, 2025
Through the Line: Packaging and Processing
Medical Devices
What Is The Goal of the GS1 US Barcode Assessment?
The Barcode Assessment revealed that while most manufacturers are now labeling medical devices with barcodes containing the mandated Unique Device Identifier (UDI), healthcare providers aren’t consistently scanning those barcodes at the point of care.
July 9, 2025
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Regulatory
Study Reveals the U.S. Pharmaceutical Firms with the Most FDA Recalls
An AI healthcare platform analyzed 13 years of FDA data to identify companies with highest recall rates and most dangerous violations.
July 7, 2025
Medidex, an AI-powered medical chatbot platform, analyzed every pharmaceutical recall from 2012 through 2024, looking at both how often companies recalled products and how dangerous those recalls were.
Regulatory
Bridging the Barcode Divide: Challenges in Medical Device UDI Implementation
GS1 US Barcode Assessment reveals that full UDI implementation is often impeded at the provider level.
July 2, 2025
The Barcode Assessment revealed that while most manufacturers are now labeling medical devices with barcodes containing the mandated UDI, healthcare providers aren’t consistently scanning those barcodes at the point of care.
Regulatory
Community Poll: Benefits of AI in Healthcare Packaging
Learn where your peers stand on the advantages of AI in healthcare packaging.
June 23, 2025
Regulatory
How AI Will Help Brands Transform Packaging Compliance and Speed to Market
RegASK’s AI tool uses machine learning, in partnership with Esko, to deliver clear, up-to-date regulatory information, helping brands keep up with changing rules in different markets.
June 23, 2025
To address the new and evolving regulations within the industry, and streamline packaging development, RegASK recently partnered with Esko, a global leader in integrated software and hardware solutions for packaging and labeling.
Regulatory
RegASK
June 20, 2025
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
For distributors, technical troubleshooting for inadequate bar codes and label quality remains challenging to resolve and onboarding new manufacturers can be difficult because it is time-consuming and highly technical.
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.
Regulatory
Avoid FDA warning letters with expert compliance strategies
Discover industry-tested approaches to strengthen quality systems and navigate regulatory scrutiny in this comprehensive guide for manufacturing professionals.
May 21, 2025
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Regulatory
Why Med Device Manufacturers Shouldn't Ignore Sterilization Cycles
While contract sterilizers hold the most responsibility to comply with EPA sterilization cycle requirements, MDMs play an important role in reducing gas exposure, says Wendy Mach, Packaging and Sterilization Expert at Canyon Labs.
May 7, 2025
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Regulatory
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
Through the Line: Packaging and Processing
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
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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.
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