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Section: Industry News > Regulatory
Traceability/Serialization
Confusion Persists Surrounding Suspect and Illegitimate Product
Under DSCSA, some manufacturers and distributors are struggling to understand which situations require a 3911 notification.
March 13, 2023
Regulatory
FDA Publishes Final Continuous Manufacturing Guidance
FDA
The Continuous Manufacturing of Drug Substances and Drug Products guidance represents proactive steps the FDA is taking to facilitate the pharmaceutical industry’s adoption of advanced manufacturing technologies.
March 7, 2023
Regulatory
Rx 360 - The International Pharmaceutical Supply Chain Consortium
February 27, 2023
Traceability/Serialization
Op-ed: Data Issues Abound as DSCSA Deadline Nears
Trading partners are working diligently to connect data systems in compliance with the Drug Supply Chain Security Act (DSCSA). But significant challenges remain ahead of the November finish line.
February 22, 2023
Industry News
Working Group Formed to Improve Medical Device Quality, Supply Chain
MedAccred
The new working group was inspired by the FDA Center for Devices and Radiological Health’s Case for Quality Initiative, which seeks to collaboratively advance the quality, safety, and effectiveness of medical devices.
February 16, 2023
Cannabis
FDA Issues Final Guidance on Human Drugs Containing Cannabis
FDA
The agency’s ‘‘Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research’’ document finalizes the draft guidance issued in 2020.
February 1, 2023
Packaging/Filling
Pharmapack Experts Predict Future of European Packaging Companies
Pharmapack Europe
Many smaller and medium-sized European packaging companies will have to grow or face being acquired in 2023, according to Pharmapack Europe experts.
January 26, 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
Traceability/Serialization
GS1 US: Why the Barcode Isn't Going Anywhere
"We’re thrilled to have deep collaboration with members like Amazon, which currently sits on our Board of Governors, to drive supply chain and ecommerce innovation while also meeting the growing needs of today’s connected consumer."
January 13, 2023
Labeling/Printing
Schreiner MediPharm to Showcase First-Opening Indication Feature
Schreiner MediPharm
The novel combination of needlestick and product protection for the company’s protective Needle-Trap solution will debut at Pharmapack Paris.
January 12, 2023
Materials
Pharmapack Europe 2024 to Have 2 New Dedicated Zones
Pharmapack Europe
The event will have the new zones in 2024 due to the growth of biologics, new modalities, and contract packaging.
January 10, 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
Materials
Counting Down the Top 10 Articles of 2022 - #7: Manage Challenges from the EU 536/2014 Clinical Trials Regulation
Join us as we look back at the most-read Healthcare Packaging stories of 2022. At #7, we cover study startup timelines, expiry labeling on primary packaging solutions, and study administration methods.
December 27, 2022
Supply Chain
HDA Issues Statement on PREVENT Pandemics Act
Healthcare Distribution Alliance (HDA)
The bipartisan legislation included in omnibus bill would bolster supply chain resilience capabilities.
December 26, 2022
Labeling/Printing
Mobile-based App
Kallik
The Kallik mobile-based app is used with the company’s Veraciti label and artwork management solution to maximize efficiency and productivity.
December 22, 2022
Packaging/Filling
Quotables and By the Numbers: November 2022
Quotes and stats on clinical trial demographics, modes of transportation, the personalized medicine market, and more...
November 21, 2022
Regulatory
FDA Issues Draft Guidance on Breakthrough Devices Program
FDA
The goal of the updates is to reduce existing disparities in health and healthcare in the U.S.
November 14, 2022
Packaging/Filling
Aphena Pharma Solutions Completes 3-Year, $20M Tennessee Expansion
Aphena Pharma Solutions, LLC
The expansion will allow the company to grow its bottle and blister packaging capacity, making Aphena a strong strategic growth partner for generic and OTC pharmaceutical companies.
November 9, 2022
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