FDA

President Obama recently signed into law H.R. 3204, which establishes national track-and-trace/serialization system and brings more federal oversight to large-volume compounding pharmacies that custom-mix medications in bulk.
Column/Opinion
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H.R. 3204 bill signed into law

Establishes national track-and-trace/serialization system and brings more federal oversight to large-volume compounding pharmacies that custom-mix medications in bulk.
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Total Cost of Ownership
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Feature Article
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The key role of equipment and packaging in food safety

As food companies are constantly looking for ways to control food safety risks, they increasingly recognize the need to ensure that their processes are fully validated and verified on an ongoing basis to be doing what they are supposed to do to control risk. They realize that they must control environmental risk and especially allergen risk.
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.
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.

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