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402 Results
Type: Article
Section: Industry News > Regulatory
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.
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.
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.
Traceability/Serialization
Cosmeceuticals Co. Completes First Phase of Serialization
Episciences, Inc.'s new track & trace system offers enhanced supply chain visibility while deterring gray market diversion for its popular skin care products. With more than several dozen unique offerings, initiating new SKUs has proven a smooth process.
June 12, 2024
Episciences was able to integrate ACSIS’ Serialization Management system without the hassle and cost of modifying existing secondary packaging artwork or labeling procedures to prioritize barcode placement.
Recyclability
Upcoming SPMC Paper to Educate Lawmakers on Sterile Packaging
“We want to highlight the critical role that sterilization packaging plays … and share the potential risks and unintended consequences that could be caused by, in essence, ill-suited policy or legislation," says Nick Packet.
May 31, 2024
Getty Images 1415423396
Traceability/Serialization
Finding the Right DSCSA Contact Remains a Challenge
Live from HDA's Distribution Management Conference: Echoing 2023 concerns, state boards of pharmacy discuss why reaching the right contact in a timely matter is so critical.
March 12, 2024
Panelists (from left): Josh Bolin, National Association of Boards of Pharmacy; Mark Klawitter, Montana Board of Pharmacy; Mark Hardy, North Dakota Board of Pharmacy; Kim Grinston, Missouri Board of Pharmacy.
Regulatory
PFAS: Navigating Materials of Concern in Life Science Packaging
From regulations to supplier inventory, how might PFAS bans impact your operations in the short- and long-term? What might be the next materials of concern?
January 23, 2024
Regulatory Pfas Getty 174197278
Pharmaceuticals
Consumer Risk Increases from Growth in Online Pharmacy Buying
A new survey reveals 60% of online pharmacy users would consider purchasing from an unapproved source for convenience, and 47% of Americans falsely believe that only safe, verified websites selling prescription drugs appear at the top of search results.
January 11, 2024
Online Pharmacy Buying
Market Trends
Top 10 Packaging and Labeling Quick Hits of 2023
News bits from around the world in packaging, labeling, and drug delivery.
January 5, 2024
Zipline Drone Medicine Delivery
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