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1,767 Results
Section: Industry News > Regulatory
Traceability/Serialization
RFID Product Tracing Through the Point of Care
CCL Healthcare
Hospitals, pharmacies, and patients can access product data—including authentication, recalls, and expiration—with a simple RFID scan or smartphone tap via smart labels from CCL Healthcare’s eAgile.
April 10, 2024
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
Preparing For Your Next FDA Inspection
Your checklist to ensure a passing grade.
November 28, 2023
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FDA Issues Draft Guidance for Biosimilar Products Labeling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
Materials
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
Logistics
HDA Traceability Seminar (Aug 29-31, 2023) and Webinar Series
Healthcare Distribution Alliance (HDA)
With Nov. 2023 approaching, HDA is holding its in-person Traceability Seminar two months early—in August—in Washington D.C., after its 3-part summer webinar series, covering tech solutions, industry recommendations for DSCSA enforcement, and more.
June 27, 2023
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