Regulatory

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.
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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.
FDASIA strengthens agency’s authority
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FDASIA strengthens agency’s authority

Reviewing provisions of the legislation that impact drug product inspections.
GS1 US has published a guideline that details how to implement GS1 Standards to support the 2013 Drug Supply Chain Security Act (DSCSA), and enhance patient safety and security in the pharmaceutical supply chain. (This photo is for illustration purposes only.)
News
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Guideline delineates how to implement GS1 standards

Document provides intelligence to support pharmaceutical lot-level management and future item-level traceability requirements
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.
Healthcare Packaging Publisher Jim Chrzan.
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FDA continues to stress manufacturing excellence

PDA/FDA Joint Regulatory Conference says global supply chain will require unprecedented cooperation.

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