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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.

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.
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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.
Kevin O'Donnell is Vice President, Cold Chain Standards, Practices & Compliance at BioLife Solutions, Inc., and is a Contributin
January 7, 2015 | Column/Opinion

Test your cold chain IQ

True or false questions about the handling of biologics and drugs in the supply chain.
Dirk Rodgers is a Contributing Editor for Healthcare Packaging and author of RxTrace.
January 7, 2015 | Column/Opinion

DSCSA answers are needed

FDA is not addressing the questions people are asking.
VIAL STOPPER. This image shows a continuous ink-jet code on a vial stopper.
January 6, 2015 | Feature Article

Comparing UDI and DSCSA coding

Although there are differences between the medical device Unique Device Identification (UDI) regulation and the Pharmaceutical Drug Supply Chain Security Act (DSCSA), Videojet Technologies’ Tim Kearns finds many common aspects across both.
December 23, 2014 | Column/Opinion

Packaging and its partners

When packagers speak of packaging, frequently they are referring to the physical structure holding a product.

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