FDA

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.
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Total Cost of Ownership
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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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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.
FDASIA strengthens agency’s authority
News
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FDASIA strengthens agency’s authority

Reviewing provisions of the legislation that impact drug product inspections.
FDA’s growing global focus faces language barriers
Column/Opinion
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FDA’s growing global focus faces language barriers

As FDA becomes more globally focused, drug complaints and adverse event reporting pose “cultural” challenges, as do inspections.
PDA developing Technical Report on drug shortages
News
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PDA developing Technical Report on drug shortages

Parenteral Drug Assn. expects to publish report on the prevention and management of drug shortages by early 2015.

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