Regulatory

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.
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!
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.
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.
Column/Opinion
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Are cosmetics regs getting a makeover?

Of all the types of products regulated by the U.S. Food and Drug Administration, cosmetics gets the lightest touch.
How will the new HHS law impact your business?
News
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August 21 Webinar: Calculate the impact of 'Obamacare' on your business

Webinar on Affordable Care Act will teach 'five steps' for avoiding penalties, and provide step-by-step instructions for calculating the law's impact.
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.
Column/Opinion
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Can't avoid thinking globally

If it's here, it’s got to comply.
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.

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