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Regulatory

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!”
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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.
Figure 1. Manufacturer A is probably acting as a contract manufacturer/packager on behalf of the NDA holder, manufacturer B.
Column/Opinion
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Working with CMOs under California e-pedigree

For different products, manufacturers may fill the role of an exclusive distributor, a contract manufacturing organization, or a repackager. Each of these would be treated differently under the California law with respect to pedigree origination and updating.
Eric Greenberg
Column/Opinion
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New FDA drug powers tougher on industry, but not without controversy

Congress added drug detention and inspection provisions, and some aspects could lead to future legal tests.
Column/Opinion
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BPA: Is it a complex story? Oh, baby.

The drama over bisphenol A has already been so complex and weird, we should have expected the latest odd chapters.
Five packs of Cook Medical products.
Feature Article
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Cook Medical meeting global identification challenges

A nearly five-year effort helps Cook and its worldwide customers identify, track, and trace some 16,000 medical device products.

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