New Tool: ProSource
Checkout our packaging and processing solutions finder, ProSource.
Subscribe
Design & Materials
Sustainability
Machinery
Logistics
Industry News
Resources
E-Commerce
Market Trends
PMMI News
Quick Hits
Regulatory
Workforce
Regulatory: Page 2
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FDA Issues Draft Guidance for Biosimilar Products Labeling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
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
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
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
Previous Page
Page 2 of 198
Next Page
Top Stories
PMMI News
Perceptions of AI in Packaging and Processing
Packaging and processing executives are finding AI can be beneficial in areas like connecting disparate machine systems and uncovering unknown problems within operations.
Medical Devices
MDMs: Submit Stability Data, Help Packaging Science!
Recyclability
HPRC Makes Strides Toward Advanced Recycling in Healthcare
Quick Hits
Novo Nordisk’s Fight Against Ozempic Counterfeits
Robotics/Automation
Top AI Applications in Packaging and Processing
Discover Our Content Hub
Access Healthcare Packaging's free educational content library!
Read More
Test Your Supply Chain Smarts
Take Healthcare Packaging's supply chain quiz to prove your knowledge!
Read More
Products
Hot Melt Barrier Film for Fridge and Freezer Label Applications
Innovia Film's Rayoface™ AQBHA is a high gloss film with two sides coated white that does not curl and is designed for hot melt coating and other two-side coated demands.
Sustainable Vials and Medical Devices
Industrial Circular Connectors
More Products
In Print
Spring 2024 Healthcare Packaging
Winter Healthcare Packaging 2023
Fall 2023 Healthcare Packaging
Spring 2023 Healthcare Packaging
Subscribe
Archives
Downloads
View more »
Home
Cobot Palletizers
Sustainability
Sustainable Healthcare & Medical Device Packaging Suppliers
Home
Healthcare Packaging's Most Popular Articles of 2023
Home
Preparing For Your Next FDA Inspection
View more »