Regulatory

Kevin O'Donnell is Vice President, Cold Chain Standards, Practices & Compliance at BioLife Solutions, Inc., and is a Contributin
Column/Opinion
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Test your cold chain IQ

True or false questions about the handling of biologics and drugs in the supply chain.
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44 Best Package Designs
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Dirk Rodgers is a Contributing Editor for Healthcare Packaging and author of RxTrace.
Column/Opinion
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DSCSA answers are needed

FDA is not addressing the questions people are asking.
Sterling Anthony, CPP
Column/Opinion
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What pot edibles portend for packaging

Marijuana-spiked edibles for recreational consumption already are legal in two states, giving new meaning to “pot pie,” and setting the table for a smorgasbord of packaging issues.
Eric F. Greenberg is a Contributing Editor and Legal & Regulatory columnist for Packaging World and Healthcare Packaging.
Column/Opinion
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What is considered a drug?

FDA Warning Letters provide reminder of the basics of drug regulation.
Eric Greenberg
Column/Opinion
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A rose by any other name would still be regulated by FDA

In recent years the proliferation of dietary supplements, which are foods intended to provide supplementation of one’s diet with a particular substance or substances, has led to many creative and innovative products.
Serialization technology
News
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Animal health medications benefit from track and trace

Serialization technology protects global pharmaceutical and biotech maker protect its flea-and-tick medications.
VIAL STOPPER. This image shows a continuous ink-jet code on a vial stopper.
Feature Article
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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.
Package Case Study
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Building products packaging meets OSHA standard

New product packaging for USG Corp.’s line of building products handily meets the deadline for OSHA’s Global Harmonization Standard, while furthering the company’s branding strategy.
Column/Opinion
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Packaging and its partners

When packagers speak of packaging, frequently they are referring to the physical structure holding a product.
Source: U.S. Food and Drug Administartion, “Pregnancy and Lactation Labeling Final Rule,” 12/3/14
News
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FDA updates drugs/biologics labeling system

Includes major revisions on pregnancy and breastfeeding, with labeling changes taking effect June 30, 2015. Prescription drugs and biologic products approved after June 30, 2015, will use the new format immediately, while labeling for prescription drugs approved on or after June 30, 2001, will be phased in gradually.

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