Subscribe
Design & Materials
Sustainability
Machinery
Logistics
Industry News
Downloads
E-Commerce
Market Trends
PMMI News
Quick Hits
Regulatory
Workforce
Regulatory: Page 16
Sustainability
Medical Device eIFUs: Hurdles to Overcome
Live from the[PACK]out: Regulations, regional acceptance, and validated packaging configurations all play a role. The challenges aren’t insurmountable but will require efforts from the packaging community.
May 12, 2022
Medical Device/Packaging
KiiP Tackles Wicked Problems in Package Material Stability
What began as a chat over coffee has led to work on a hypothesis and a white paper with far-reaching potential in saving time and resources in medical device packaging stability testing. Efforts were presented at the[PACK]out's inaugural event in Austin.
May 10, 2022
Inspection
FDA Permits Marketing for Test to Improve Diagnosis of Alzheimer’s Disease
U.S. Food & Drug Administration
The Lumipulse test is intended to measure the ratio of β-amyloid 1-42 and β-amyloid 1-40 concentrations found in human cerebral spinal fluid.
May 6, 2022
Market Trends
Quotables and By the Numbers: May 2022
Quotes and stats in healthcare packaging and logistics, from distribution to sustainability and beyond...
May 3, 2022
Regulatory
the[PACK]out:Â Supply Chain - Navigating Disruptions
EXPERIENCE the[PACK]out: Created for industry professionals, by industry professionals.
April 26, 2022
Regulatory
FDA Issues New Guidance to Increase Racial and Ethnic Diversity in Clinical Trials
U.S. Food & Drug Administration
The agency’s focus on inclusion in trials for all medical products aligns with Biden Administration’s Cancer Moonshot goal of addressing inequities and beyond.
April 22, 2022
Traceability/Serialization
HDA Guidelines for Bar Coding in Pharmaceutical Supply Chain Available
Healthcare Distribution Alliance (HDA)
The document serves as a resource on the use of GS1 system data structures and symbologies to comply with the Drug Supply Chain Security Act’s serialized product and data requirements.
April 18, 2022
Medical Device/Packaging
Cybersecurity in Medical Devices: FDA Announces New Draft Guidance
U.S. Food & Drug Administration
The new guidance deals with quality system considerations and the content of premarket submissions for members of the medical device industry, as well as Food and Drug Administration staff.
April 15, 2022
Temp Control/Cold Chain
10 Temperature Monitor Qualification Considerations
From the 2022 ISTA Forum TempPack: Panelists discussed the latest on temperature recording device (TRD) qualification, including dry ice and LCD screens, probes that disconnect, and what to consider before selecting a shipper integrated with a TRD.
April 15, 2022
Medical Device/Packaging
FDA Recommends Use of Duodenoscopes With Innovative Designs to Enhance Safety
U.S. Food & Drug Administration
The agency is providing new information supporting the transition to fully disposable duodenoscopes and those with disposable components, as well as new information on completed post-market surveillance studies.
April 8, 2022
Traceability/Serialization
Rx Supply Chain Progressing on EPCIS Adoption for DSCSA, Yet Challenges Remain
Healthcare Distribution Alliance (HDA)
HDA Research Foundation’s latest EPCIS Implementation Benchmarking Survey assesses industry progress of adopting GS1 Electronic Product Code Information Services (EPCIS) and trading partner plans for sending data.
March 21, 2022
Labeling/Printing
Solution for Expiry Labels, DtP, and Study Timelines Due to EU 536/2014 Clinical Trials Regulation
The new regulation improves many aspects of clinical preparation and activation but brings certain new challenges for sponsors.
March 18, 2022
Previous Page
Page 16 of 189
Next Page
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
In Print
Fall 2026 Healthcare Packaging
Spring 2026 Healthcare Packaging
Fall 2025 Healthcare Packaging
Spring 2025 Healthcare Packaging
Subscribe
Archives
Downloads
View More »
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
View More »
![At the[PACK]out, presenting 'Wicked Stability: Predicting the Aging Degradation of Materials' were speakers (from left): Dan Burgess, Henk Blom, and Rod Patch w/ Moderator Seema Momin.](https://img.healthcarepackaging.com/files/base/pmmi/all/image/2022/05/Wicked_Stability.627af09af0762.png?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
