FDA

Eric F. Greenberg is a Contributing Editor and Legal & Regulatory columnist for Healthcare Packaging.
Column/Opinion
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How do you like your FDA?

Would lower government burdens on industry provide sufficient protection for the public?
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Dirk Rodgers
Column/Opinion
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A perspective on DQSA, preemption, and pedigree

Now that DQSA is law, any previous investments to meet California pedigree law can be repurposed to meet the new federal law.
Author Katherine Eban’s (shown here) book “Dangerous Doses,” exposed the dark side of America’s pharmaceutical trade. Here, the investigative journalist looked at the epic inside story of long-term criminal fraud at Ranbaxy, the Indian drug company that makes generic Lipitor for millions of Americans.
Column/Opinion
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Your Top 10 Healthcare Packaging stories from 2013

Serialization stories dominated the list among Healthcare Packaging online readers, but the top-read story of the year revealed some dirty deeds.
Column/Opinion
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Off-label uses: some can talk about them, some cannot, and something’s gotta give

When it comes to FDA regulation of ‘off-label’ uses of legally marketed drugs and devices, there’s a lot that’s odd.
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.
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.

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