All the latest packaging trends for life sciences, all at PACK EXPO East
Explore new packaging solutions for life sciences, all in one convenient location at PACK EXPO East, March 18 – 20 in Philadelphia.
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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
FDA Issues Draft Guidance for Biosimilar Products Labeling
The guidance explains what relevant data and information from the reference product labeling should be incorporated into biosimilar and interchangeable biosimilar product labeling.
November 10, 2023
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
Regulatory
FDA Issues Drug Development Benefit-Risk Assessment Guidance Document
U.S. Food and Drug Administration
The agency has released its “Benefits-Risk Assessment for Human Drug and Biological Products” final guidance to provide a clearer understanding of the FDA's decision-making context and benefit-risk considerations in drug development.
October 23, 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
Regulatory
FDA Issues Final Guidance for Use of ISO 10993-1 for Medical Devices
FDA
The document provides further clarification and updated information on the use of International Standard ISO 10993–1, “Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process.”
September 14, 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
FDA Extends Enhanced Drug Distribution Security Requirements Deadline
The agency has announced a one-year delay in the DSCSA requirements for system-wide electronic interoperable systems to be put in place and how to request a waiver, exception, or exemption.
August 29, 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
Regulatory
FDA, DEA Taking Action to Rectify Prescription Stimulants Shortage
The agencies recently sent a joint letter to manufacturers to confirm they are working to increase their production of the drugs and, if they’re not, to do something about.
August 15, 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
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Top Stories
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.
PMMI News
PACK EXPO East Launches with Record-Breaking Attendance
Medical Device/Packaging
FDA Warning: Exactech Shoulder Implants at Risk of Oxidation
PMMI News
PACK EXPO East Brings the Latest Packaging and Processing Technologies to Philadelphia
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