FDA

Regulatory issues represented the primary challenge for combination product makers, closely followed by processing and manufacturing, and then fill/finish and packaging. These details provide keen insight into manufacturer needs, particularly for consultants and suppliers involved in these topical areas.
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Regulatory burdens weigh on combination product manufacturers

Regulatory matters, processing and manufacturing, as well as fill/finish and packaging rank as the most challenging areas for makers of combination products.
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Senator Charles Schumer calls for safer packaging for children’s medicine bottles in effort to help prevent emergency room visits.
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Could 'flow restrictors' help reduce medication overdoses?

Senator Charles Schumer calls for safer packaging for children’s medicine bottles in effort to help prevent emergency room visits.
Gail E. Radcliffe, Ph.D., is President of Radcliffe Consulting, Inc.
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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.
Shown in this photo is a fake Lamisil three-pack.
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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.
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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.
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.
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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.

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