Regulatory

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.
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!
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.
The first new EU guidelines for GDP of medicinal products for human use since 1994 include new information on quality risk management, transportation, and more.
News
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New EU GDP includes new/enhanced guidelines

The first new EU guidelines for GDP of medicinal products for human use since 1994 include new information on quality risk management, transportation, and more.
Column/Opinion
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Industry wins a Proposition 65 battle but more ahead

For industry, dealing with California’s Proposition 65 reminds me of the advice Harry Potter got from one of his teachers about how to defend against you-know-who: “Constant vigilance!”
The U.S. House passed a track-and-trace and compounding bill.
News
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U.S. House passes track-and-trace bill

H.R. 3204 now awaits Senate approval. If passed into law, the new bicameral bill would preempt California e-pedigree and give industry more time to comply.
David Stoklosa
Column/Opinion
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Sauce, dip, salsa, and spirits maker/co-packer discusses expansion and staffing

David Stoklosa, Director, Corporate Business Development, LiDestri Foods, Inc., discusses facility and equipment investment, staffing, and business development issues.
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.
A stock image portraying packaged medical marijuana.
News
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Container company supports child-proof packaging for marijuana products

Medical wellness container wholesale distributor Kush Bottles to urge Colorado lawmakers to support Task Force recommendation.

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