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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.

Healthcare packaging seminar May 6-7, 2014 to address challenges faced in China, including medical package design, validation, and regulatory issues.
April 15, 2014 | News

First LifePack Forum slated for Suzhou, China

Healthcare packaging seminar May 6-7, 2014 to address challenges faced in China, including medical package design, validation, and regulatory issues.
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By establishing an Office of Pharmaceutical Quality, FDA hopes to spur pharmaceutical manufacturers to address batch process, packaging, and other problems impacting the supply chain.
April 11, 2014 | Feature Article

FDA wants pharma to move from compliance to quality

By establishing an Office of Pharmaceutical Quality, FDA hopes to spur pharmaceutical manufacturers to address batch process, packaging, and other problems impacting the supply chain.
This photo shows an authentic alli carton.
March 31, 2014 | News

GlaxoSmithKline voluntarily recalls alli weight loss product

Company believes some packages of the product were tampered with, leading to recall of all alli products from U.S. and Puerto Rico retailers.
President Richard M. Johnson of The Parenteral Drug Assn.
March 27, 2014 | Column/Opinion

A Washington perspective on healthcare packaging

Visits to PDA, USP, RAPS, and CPSC reveal what works "Inside the Beltway."
Jay Leno is scheduled to liven up Pack Expo proceedings Nov. 3 in Chicago.
March 19, 2014 | News

Jay Leno to liven up Pack Expo proceedings

Also, Pharma Expo will be co-located with Pack Expo in “one of the most exciting developments in recent PMMI history.”
Dr. Michael Drues is President of Grafton, MA-based Vascular Sciences, an education, training, and consulting company. He can be reached on Linkedin®, by phone at 508.887.9486, and by e-mail at mdrues@vascularsci.com
March 17, 2014 | Column/Opinion

10 questions for the future of medicine, circa 2024

The global healthcare community’s responses to these 10 questions could have a profound impact on the future of medicine—and its packaging.
HealthPack 2014 in Albuquerque included a number of exhbitor booths.
March 12, 2014 | News

Are medical device manufacturers overwhelmed with standards?

Medical device standards and regulations generate discussion at HealthPack 2014’s opening day.
Desmond Hunt addressed U.S. Pharmacopeia issues at PDA Europe 2014.
March 12, 2014 | News

PDA Europe addresses regulatory and standards issues

Regulatory and standards agencies must move forward to take into account complex biologics, single-use manufacturing, improved testing methods, etc. And in some cases they must look back at current regulations and ask, how did this get in here in the first place, and is it still relevant today?
Eric Greenberg is Principal Attorney at Eric F. Greenberg P.C., a law firm that concentrates its practice in food and drug law, packaging law, and commercial litigation. He can be reached at greenberg@efg-law.com or at 312-977-4647.
March 11, 2014 | Column/Opinion

Packaging adds safety, other benefits

The recently passed DQSA law is an important part of the picture, but only part of the story of how packaging’s role in safety is increasing.
Dirk Rodgers, who contributed to Healthcare Packaging’s Pharmaceutical Serialization Playbook, is an independent consultant and founder of RxTrace.
March 4, 2014 | Column/Opinion

The future of healthcare supply chain security

We know more about how healthcare supply chain security will work in 2024 than looking forward in any previous 10-year period.

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