FDA

Sales pitch PW
Column/Opinion
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A revolution in drug label regulation?

A federal appeals court recently said FDA could not legally prohibit a drug company salesman from promoting off-label uses of its drug. Here’s what this could mean to drug manufacturers, and to FDA.
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MHRA Pangea
News
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FDA takes action against thousands of illegal Internet pharmacies

More than 100 countries participate in Operation Pangea V to protect consumers from potentially dangerous, unapproved drugs sold online. BeSafeRx launched to help consumers.
Global currency and regs
Feature Article
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Regulatory perspectives with a global twist

Pharmaceutical and medical device leaders think globally when it comes to regulatory matters of importance to packaging.
FDA Teva Adderall
News
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Filling errors, counterfeit packs gain FDA’s attention

Hospira’s prefilled cartridges are overfilled, but not recalled. Counterfeit versions of Teva’s Adderall use wrong package, with print misspellings.
Kallik study
Feature Article
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Managing language complexity a pharmaceutical packaging challenge

Research by artwork management firms points to text and regulatory challenges in labeling and packaging for different countries.
BD GTIN
Feature Article
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Becton, Dickinson takes proactive stance on device identification

Medical technology company/Mercy Health System’s joint packaging data integration program includes some 650 products and 950 global trade ID numbers.
JETT logo
News
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JETT seeking input on User Requirement Specifications

Two current projects include revising URSs to a new tablular format and developing URSs for serialization.
Column/Opinion
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Cosmetics legal changes on the way?

Cosmetics are regulated by the Food and Drug Administration with the lightest of touches.
Consumer with can
News
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FDA to respond to petition to ban BPA

While the agency weighs evidence that both supports and opposes the controversial chemical, consumers may make the ultimate decision.
Labeled pill bottles
News
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FDA amends packaging/labeling provisions on cGMP regs for drugs

Final ruling goes into effect March 20, 2013; aims to prevent label mix-ups, protect consumers, and eliminate regulatory burden.

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