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1,882 Results
Section: Industry News > Regulatory
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
Traceability/Serialization
Op-ed: Collaboration Is Critical for DSCSA Stabilization
The FDA recently announced a DSCSA “stabilization policy,” but further clarity and education will be needed for all trading partners to ensure they reach compliance.
October 26, 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
Medical Device/Packaging
thePACKout 2024 Call for Abstracts is OPEN
October 6th is the last day to submit abstracts (submission site closes at 11:59 PM EST).
September 27, 2023
Adherence/Delivery
FDA Approves OTC Designation for Vonco’s Enteral Feeding Solution
Vonco Products, LLC
EnteraLoc Flow is the first seamless, closed-loop enteral feeding solution that combines a spill-proof pouch, direct-connect ENFit® device, tube, and nutritious food options in a single, complete feeding system.
September 26, 2023
Home
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
Antares Vision Group Joins NABP Pulse Interoperable Partner Program
Antares Vision Group
AVG becomes the first DSCSA solution provider to join the program, demonstrating and extending the company’s commitment to DSCSA compliance.
September 7, 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
Traceability/Serialization
HDA Statement on FDA Enforcement Discretion for the DSCSA’s Final Implementation Requirements
“Given the interdependency of the pharmaceutical supply chain, successful implementation of the DSCSA is predicated on all trading partners having systems and procedures tested and ready to go for unit-level serialization," adds HDA's Chip Davis, Jr.
August 25, 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
Supply Chain
Department of Labor Launches Program to Address Workplace Hazards
U.S. Department of Labor
The OSHA national emphasis program is aimed at preventing and reducing workplace hazards in warehouses, distribution centers, and more.
August 1, 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
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