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FDA

What does the recently ended government shutdown mean for the healthcare community?
Column/Opinion
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The healthcare community and the government shutdown

What’s the impact from the just-ended shutdown for makers of pharmaceuticals, biologics, and medical devices? Give us your opinion.
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42 Best Package Designs
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Feature Article
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Food safety factors driving equipment upgrades

New regulations, the global food supply chain, changing science, consumer expectations, the Internet-enabled speed with which illnesses are reported and other factors all play a role on equipment upgrades.
TRAXSECURE UNALTERED. The TraxSecur™ security feature is printed, without a requirement for any special inks, as a background that looks similar to those seen on security paper, except that it is created as a unique “instance” relating to a single time and place, which inextricably links an individual package to its unique corresponding track-and-trace information; this is Serialized Security™.
Feature Article
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Update on serialization and unique device identification regulatory developments

Key regulatory developments could preempt California e-pedigree and provide clarity for manufacturers and packagers of pharmaceuticals, biologics, and medical devices.
At the 11th Annual Cold Chain GDP & Temperature Management Logistics Global Forum, some 80 companies had exhibits to showcase their products and technologies.
Column/Opinion
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Cold chain event embraces all links in the pharmaceutical supply chain

Cold Chain Global Forum acknowledges that all distribution and logistics stakeholders, from packaging suppliers to patients, must be involved in successful temperature management efforts.
FDA issues final ruling on UDI.
News
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FDA finalizes new system to identify medical devices

Agency says the rule will help to improve patient safety.
UPS survey shows supply chain issues in North America.
News
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UPS survey finds global healthcare executives driving supply chain transformation to reach new markets

Investments planned in areas such as technology amid growing concerns over product protection, global regulatory environment.
Figure 1. Manufacturer A is probably acting as a contract manufacturer/packager on behalf of the NDA holder, manufacturer B.
Column/Opinion
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Working with CMOs under California e-pedigree

For different products, manufacturers may fill the role of an exclusive distributor, a contract manufacturing organization, or a repackager. Each of these would be treated differently under the California law with respect to pedigree origination and updating.
Eric Greenberg
Column/Opinion
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New FDA drug powers tougher on industry, but not without controversy

Congress added drug detention and inspection provisions, and some aspects could lead to future legal tests.
Five packs of Cook Medical products.
Feature Article
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Cook Medical meeting global identification challenges

A nearly five-year effort helps Cook and its worldwide customers identify, track, and trace some 16,000 medical device products.
Mortar Pestle image
News
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Specialty Compounding, LLC issues nationwide voluntary recall

Recall follows reports of bacterial infection affecting patients at two Texas hospitals.

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