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?
E-BOOK SPECIAL REPORT
42 Best Package Designs: 2014 edition
Sign up to receive timely updates from our editors and download this e-book consisting of our editors' picks of most notable package designs. Updated for 2014!
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.
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.
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.

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