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.

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.
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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.
Dirk Rodgers, who contributed to Healthcare Packaging’s Pharmaceutical Serialization Playbook, is an independent consultant and founder of RxTrace.
November 3, 2014 | Column/Opinion

UDI vs the DSCSA

The FDA's enforcement of these two regulations could be different, because of where they originated.
Eric F. Greenberg is a Contributing Editor and Legal & Regulatory columnist for Packaging World and Healthcare Packaging.
October 31, 2014 | Column/Opinion

Navigating FDA recall requirements

A medical device recall by any other name might still stink for your company.
Serialization technology protects global pharmaceutical and biotech maker protect its flea-and-tick medications.
October 30, 2014 | News

Animal health medications benefit from serialization technology

Serialization technology protects global pharmaceutical and biotech maker protect its flea-and-tick medications.
National Medical Device Curriculum addresses learning needs; aims to advance medical device development through a case-study approach.
October 23, 2014 | News

FDA helps small medical device companies innovate quicker

National Medical Device Curriculum addresses learning needs; aims to advance medical device development through a case-study approach.
FDA announcements touch upon healthcare packaging and regulatory issues
October 20, 2014 | News

FDA announcements touch upon healthcare packaging and regulatory issues

Agency addresses increasing complexity of FDA’s mandate, globalization in the supply chain, and the trend of rapid scientific innovation.
October 16, 2014 | News

Roche's Ebola Virus Test Could Be Fast-Tracked by FDA

Laboratories who want to handle Ebola samples would have to meet specific safety requirements.

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