Serialization Playbook newly revised with updates on new legislation

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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.

December 17, 2014 | News

November 2014 FDA Safety Labeling Changes

The list includes 30 products.
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Examining the different approaches or the traditional qualification model and the risk-based system now being encouraged by regulators.
December 16, 2014 | News

Quality risk management: an industry/regulatory perspective

Examining the different approaches for the traditional qualification model and the risk-based system now being encouraged by regulators.
Expiries of leading drugs to cause huge financial losses for pharmaceutical firms by 2019, predicts GlobalData.
December 10, 2014 | News

Patent cliff to cause $65 billion sales loss

Expiries of leading drugs to cause huge financial losses for pharmaceutical firms by 2019, predicts GlobalData.
December 4, 2014 | News

Is the FDA stalling on biosimilars?

Lawmakers want the FDA to move quickly when it comes to biosimilars.
Source: U.S. Food and Drug Administartion, “Pregnancy and Lactation Labeling Final Rule,” 12/3/14
December 3, 2014 | News

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.
Systec & Solutions: HMI systems
December 2, 2014 | Controls Product Brief

Systec & Solutions: HMI systems

Stainless-steel HMI systems are suitable for life science and food industries.
FDA issues guidance for outsourcing facilities
November 21, 2014 | News

FDA issues guidance for outsourcing facilities

Aims to assist entities that compound sterile human drugs; available for comment in Federal Register for 60 days.
In this Q&A, Chip Meyers, VP, Corporate Public Affairs, UPS, offers perspective on serialization and track and trace for medical devices and pharmaceuticals.
November 17, 2014 | Column/Opinion

A common-sense perspective on UDI and DSCSA

In this Q&A, Chip Meyers, VP, Corporate Public Affairs, UPS, offers perspective on serialization and track and trace for medical devices and pharmaceuticals.
DePuy Synthes, Stryker, Medtronic speakers highlight HealthPack 2015
November 14, 2014 | News

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.
November 9, 2014 | News

Shift in Congress gives hope to repeal of medical device tax

At minimum, a reduction of the medical device tax could happen as the GOP takes over the Senate, analysts predict.

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