Regulatory

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.
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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.
Vita Health
News
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Vita Health Products conducts voluntary recall

Packaging suggests product is child-resistant, but cap is not child-resistant.
PDA booth
News
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Personalized medicine: A 'batch' of one

Flexible manufacturing approaches called for in personalized medication treatment strategies.
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.
OTC pack
News
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FDA considering waiving some prescription requirements

Agency to seek public input on allowing popular meds to switch from Rx-to-OTC to improve patient access to certain meds, which could impact package design and labeling.
Materials Product Brief
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Drug delivery devices

Two new electronic delivery eDevice platforms, e-Dose Counter and e-Lockout from Aptar Pharma are specially aimed at improving patient compliance.

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