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Regulatory

Gail E. Radcliffe, Ph.D., is President of Radcliffe Consulting, Inc.
Column/Opinion
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Regulatory issues factor heavily into the IVD market

In this question-and-answer dialogue, Gail Radcliffe of Radcliffe Consulting discusses in vitro diagnostics, focusing on regulatory and labeling issues.
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Shown in this photo is a fake Lamisil three-pack.
Column/Opinion
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Counterfeit med market grows worldwide

DQSA to help address global counterfeit drug market, recently estimated at more than $430 billion annually by the WHO.
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?
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.
Column/Opinion
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Rules are rules and are a lot of work

It’s a lot of work.
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.
FSMA’s Preventive Controls and Foreign Supplier Verification provisions are of particular relevance to food packaging suppliers.
Feature Article
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Key implications of FSMA for food packaging suppliers

Understanding the impact of FDA's Preventive Controls provision and Foreign Supplier Verification Program (FSVP) js key to helping packagers navigate the Food Safety Modernization Act.
Industry leaders praise Senate passage of H.R. 3204 bill with enhanced track-and-trace initiatives for the pharmaceutical supply chain.
News
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GS1, UPS hail Senate passage of H.R. 3204

Industry leaders praise bill with enhanced track-and-trace initiatives for the pharmaceutical supply chain.

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