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FDA, Regulatory & Legal Developments in Healthcare Packaging

Articles examine the legal and regulatory developments in healthcare packaging. Topics discussed include guidances, rulings and governmental issues that affect the packaging of drugs, biologics, and medical devices. Legal and regulatory experts from around the industry provide columns that offer depth and insight to these key issues.

Recipharm, a contract development and manufacturing organization, announced its readiness for serialization.
January 30, 2015 | News

Recipharm delivers serialization project in China

Contract development and manufacturing organization works with unnamed pharmaceutical company, resulting in 57 successful batches since Feb. 2014.
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January 29, 2015 | News

First generic version of Nexium approved

Ivax Pharmaceuticals, Inc. has gained approval to market esomeprazole in 20 and 40 milligram capsules.
January 29, 2015 | News

Report looks at timeliness of FDA approvals

Although FDA drug and device approval time is improving, consistency needs to be key.
Flexible packaging company Vonco encourages medical laboratories to seek independent testing to encourage compliance.
January 28, 2015 | Column/Opinion

Are biohazard pressure bags meeting federal regulations?

Flexible packaging company encourages medical labs to seek independent testing to ensure compliance.
PDA’s Berlin conference sheds light on manufacturing and logistics, serialization, and regulatory pressure for temperature contr
January 23, 2015 | Column/Opinion

Ensuring product integrity and visibility across the supply chain

PDA’s Berlin conference sheds light on manufacturing and logistics, serialization, and regulatory pressure for temperature control of warehouses and shipments.
Noven Pharmaceutical's incoming inspection area is used to verifiy incoming materials for copy, Braille, and barcodes.
January 21, 2015 | Feature Article

Noven upgrades its automated proofreading

Miami-based Noven Pharmaceuticals’ uses automated proofreading with Braille measurement and reading.
Bausch Advanced Technology Group: IV bag filler
January 19, 2015 | Machine Product Brief

Bausch Advanced Technology Group: IV bag filler

A new IV bag filling and closing system produces 1,600 bags/hr.
Desmond Hunt, Ph.D., Senior Scientific Liaison, U.S. Pharmacopeial Convention (USP)
January 19, 2015 | Column/Opinion

Biologics and USP’s General Chapters on Container Closure Systems

Biologics present new challenges for packaging systems.
Comar: Closures
January 15, 2015 | Materials Product Brief

Comar: Closures

A new SecureCap closure is available for eye drops and nasal sprays that require child-resistant packaging.
Eric F. Greenberg is a Contributing Editor and Legal & Regulatory columnist for Packaging World and Healthcare Packaging.
January 8, 2015 | Column/Opinion

What is considered a drug?

FDA Warning Letters provide reminder of the basics of drug regulation.

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