FDA

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.
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42 Best Package Designs: 2014 edition
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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.
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.
Mortar Pestle image
News
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Specialty Compounding, LLC issues nationwide voluntary recall

Recall follows reports of bacterial infection affecting patients at two Texas hospitals.
Illegal online sales of pharmaceuticals led to FDA taking action against more than 9,600 Web sites.
Column/Opinion
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Online pharmacy crackdown: Serious action for a complex problem

Operation Pangea VI takes action against 9,600 Web sites, seizing and shutting down 1,677 Web sites.
BD recently entered the pharmaceutical industry with a new line of generic prefilled injectable products called BD Simplist. One of the first two drugs launched is BD Simplist™ Metoclopramide Injection, USP. Both its outer package and the inner container are printed with a 2D barcode and with the NDC, serial number, lot number, and expiration date "human readable."
Feature Article
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A reprieve from California e-pedigree?

House and Senate serialization bills could push back packaging line expenditures, but wouldn’t do much to counter pharmaceutical counterfeiting.
GS1 conference image
News
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UDI for medical devices at top of the GS1 Connect agenda

LIVE FROM GS1 CONNECT: Unique Device Identifier for medical devices promises a myriad of benefits, but questions remain.
Feature Article
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Pharmaceutical serialization: Should you wait?

Exclusive Healthcare Packaging survey reveals half have yet to begin serialization projects, and more than 25% don’t plan to spend money on serialization this year!
FDA Enforcement Statistics Summary
Column/Opinion
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Enforcement Statistics, Fiscal 2012, published by FDA

The U.S. Food and Drug Administration compiled and published these data about its enforcement activities during fiscal 2012 (October 1, 2011 to September 30, 2012).
Sample codes for UDI story
Column/Opinion
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UDI: Bane or benefit? You decide

Packaging and labeling professionals may be best prepared to help their organizations navigate Unique Device Identification.

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