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337 Results
Type: Article
Section: News > Regulatory
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
State and Federal PFAS Regulations Tightening
Companies need to be mindful of both incoming PFAS regulations and how PFAS might be present in their operations to stay safe from legal trouble.
November 10, 2023
PACK EXPO Las Vegas 2023
Shipping Label Software Offers Color Boost for Dynamic Content
Epson’s new Label Boost system creates colorful shipping labels for compliance, ads, and more.
September 23, 2023
Traceability/Serialization
What Does a DSCSA Stabilization Period Mean?
From the HDA Traceability Seminar: FDA announced a DSCSA stabilization period through Nov. 2024 but is urging all trading partners not to take their feet off the gas. Consistent work will be needed from trading partners throughout the next 15 months.
September 1, 2023
Regulatory
Specific Machine and Production Environment Standards
Specific machine and production environment standards may apply to machines like conveyors and robots, or to industries that require hygienic design.
August 17, 2023
Package Design
ISTA European Packaging Symposium will Bring Together Global Transport Packaging Leaders to Focus on E-Commerce, Sustainability, and More
The European Packaging Symposium will be held September 27-28, 2023, at the Amsterdam Marriott Hotel in Amsterdam, Netherlands. Speakers include Hello Fresh and Amazon. A new track will focus on temperature-sensitive life science product distribution.
August 4, 2023
Traceability/Serialization
Tackling DSCSA Communication Issues
For trading partners, finding the right serialization contact up or downstream can be needlessly difficult. A new service—currently piloting—seeks to centralize this information and streamline communication.
July 27, 2023
Traceability/Serialization
Why Pharma Traceability is Critical in Healthcare Packaging
Learn about pharma traceability and the prevalent technologies used for it, such as serialization, RFID, barcoding, and blockchain.
July 24, 2023
Regulatory
Annex 1 Implementation Tips for CDMOs, ATMP Producers, and Sterile Manufacturers
Experts from PDA’s Annex 1 task force provide insight on compliance with the new requirements and suggestions for delayed implementation dates.
July 17, 2023
Traceability/Serialization
Op-ed: Phased Approach to DSCSA an Alternative to Nov. 27 Disruptions
The pharmaceutical supply chain is not where it needs to be as the DSCSA deadline approaches. A new approach is necessary to ensure the safe and secure delivery of medicines come November.
July 6, 2023
Events
Live from GS1 Connect: J&J Beating 2027 Sunrise on UDI
The healthcare giant continues its nine-year migration from UDI to 2D GS1 DataMatrix.
June 8, 2023
Cold Chain/Temperature Control
Merck Expert Shares 5 Tips for Qualifying Pallet-Sized Thermal Shippers
Find out why Lee Menszak advocates for shipper-to-shipper variability testing from his talk at ISTA’s TempPack event.
May 24, 2023
Regulatory
Rare Disease Patient and Advocate Talk Actions You Can Take
“We don't believe patients should have to start their own drug company to save themselves or save their child,” says Julia Jenkins, policy expert, at the PDA Annual Meeting.
April 3, 2023
Medical Device/Packaging
Roundtable Ahead of Pharmapack Europe Talks Drug Delivery Trends
From patient-centricity in a connected world to holistic sustainability strategies and proposed MDR amendments, hear what consultants have to say about the changing medical device landscape in 2023.
January 20, 2023
Regulatory
Counting Down the Top 10 Articles of 2022 - #1: Pitfalls to Avoid in FDA Aseptic Manufacturing Inspections
Join us as we look back at the most-read Healthcare Packaging stories of 2022. At #1, from personnel to facility design to process, FDA policy advisor provides an outline of what facilities can improve on.
January 4, 2023
Regulatory
FDA’s Proposed Change to NDC: Comments Due Nov. 22, 2022
The NDC proposal is intended to minimize the impact of “running out of ten-digit national drug codes (NDCs) by adopting a single, uniform 12-digit format for FDA-assigned NDCs.”
November 1, 2022
Traceability/Serialization
How Missing Traceability Data Might Affect Pharmacy Patients
If accurate and complete pharma traceability data isn't supplied to pharmacists, they may end up scrambling to serve the patients in front of them. Pharmacy leaders discuss how this may affect relationships with nonconforming trading partners.
October 14, 2022
Traceability/Serialization
DSCSA: Labels Practically as Important as the Medicine Itself
In becoming compliant with interoperable data exchange requirements under DSCSA, don’t overlook the pharmaceutical label itself. Missing case labels or faded inks can pose threats.
October 4, 2022
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