Regulatory

Eric Bronander
News
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LIVE FROM Pharma EXPO: Compliance Lifecycle and TCO

Serialization is a program, not a process, says Innovation Stage speaker.
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Eric Greenberg
Column/Opinion
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Food safety regulations are a growth industry

When you read the regulations FDA made to give effect to the Food Safety Modernization Act, it’s hard to avoid one overwhelming thought: Food safety is important, sure, and prevention is better than chasing after problems, but gee whiz, there has to be a better way, or at least a less complicated way.
Innovation Stage.
News
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PMMI releases final Innovation Stage schedule

Presenters to address food safety regulatory compliance, child-resistant packaging, automation, workforce engagement, and more at PACK EXPO Las Vegas and Pharma EXPO 2015.
Eric F. Greenberg is a Contributing Editor and Legal & Regulatory columnist for Packaging World and Healthcare Packaging.
Column/Opinion
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What’s a regulatory crime?

Violations of the FDA’s requirements can put you in jail for a misdemeanor even if you didn’t intend to commit them.
Industrial silos.
Column/Opinion
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Regulations, ‘silos’ slow pharmaceutical serialization progress

In this opinion piece, Healthcare Packaging Publisher Jim Chrzan suggests focusing on change management, looking outside pharma, and questions the promise of global harmonization.
PCI line with serialization.
News
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Contract packager unveils technology for meeting serialization requirements

PCI’s ‘FlexLine’ standalone service compliments a company’s integrated serialization technologies.
Detergent pods
News
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ASTM standard to improve safety of detergent pods

A new safety standard for liquid laundry detergent packets will detail packaging performance requirements to reduce the risk of accidental ingestion by children.
Animal vaccine label, for illustrative purposes only.
News
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FDA issues draft guidance on labeling for new animal drugs

Describes what the agency considers when deciding to take regulatory action; public comments accepted until 60 days after it publishes in the Federal Register.
Biosimilars image supplied by Allied Market Research
News
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Report examines biosimilars market drivers

Manufacturers see opportunity as blockbuster biologics face patent expiries, with emerging markets representing an easier ‘launching pad’ for biosimilars/follow-on biologics.
Wendy Buckley, President and Founder of Specialty Transportation and Regulatory Services
Column/Opinion
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HM-251—It’s not just for crude oil anymore

Just a few months after HM-251 was published, there are already multiple appeals and at least two lawsuits.

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