Regulatory

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.
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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.
DePuy Synthes, Stryker, Medtronic speakers highlight HealthPack 2015
News
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DePuy Synthes, Stryker, Medtronic speakers highlight HealthPack 2015

Topics to be covered March 3-5, in Virginia Beach will include technology for manufacturing innovation, package design, sealing process validation, and a local operating nurse panel.
Column/Opinion
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Food Contact Substance

We in the packaging industry have gotten fairly accustomed to the regulations covering packaging for food and drugs because the FDA is the regulatory body in the U.S. that covers the majority of food packaging issues.
Column/Opinion
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An interesting rulemaking, if you like that sort of thing

In today’s column, I try to persuade you that the way FDA has lately been making regulations is unusual, surprising, and interesting.
Eric F. Greenberg is a Contributing Editor and Legal & Regulatory columnist for Packaging World and Healthcare Packaging.
Column/Opinion
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Navigating FDA recall requirements

A medical device recall by any other name might still stink for your company.
Kevin O’Donnell, Senior Partner, Exelsius, is a noted authority in supply chain integrity.
Column/Opinion
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Reevaluating drug product stability can save millions on packaging

Kevin O’Donnell, Senior Partner, Exelsius, is a noted authority in supply chain integrity. In this Q&A he lends his “big-picture” insights regarding distribution practices for time and temperature-sensitive pharmaceutical/biological products.

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