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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’s GE salmon announcement sparks controversy
November 20, 2015 | Feature Article

FDA’s GE Salmon Announcement Sparks Controversy

Agency announces genetically engineered salmon is safe, drawing a CFS lawsuit. Salmon will be regulated under new animal drug provisions. GE products also have labeling implications.
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FDA takes action on dietary supplements.
November 19, 2015 | News

FDA takes action to protect consumers from potentially dangerous dietary supplements

Joint government agency sweep culminates with announcement of criminal charges against USPlabs. False labeling, misbranding identified as part of the problem.
QuickSTAT temperature-controlled facility in Belfast, Ireland.
November 10, 2015 | News

Just-in-Time Global Logistics Program

QuickSTAT partners with Almac Group to develop a temperature-controlled packaging management system to strengthen their global supply chain.
Banding pyramid.
November 5, 2015 | Feature Article

11 questions to help you protect pharma packaging personnel

Concerns over contamination often overshadow concerns for workers’ safety. Highlighted here are key questions to ask during your risk evaluation.
Eric F. Greenberg is a Contributing Editor and Legal & Regulatory columnist for Packaging World and Healthcare Packaging.
October 15, 2015 | Column/Opinion

Odd advertising lessons

Kim Kardashian will now teach us about drug advertising.
Medical devices
October 14, 2015 | Controls Case Study

Medical device firm wins with barcode labeling software

CFR enterprise barcode labeling software helps QTS reduce risk, increase efficiency, and become compliant with UDI and FDA 21 CFR Part 11 regulations.
Amsterdam is the site for PDA Europe
October 6, 2015 | News

Watch for ‘smart coolers’ for patients

TR 72— Passive Thermal Protection Systems for Global Distribution: Qualification and Operational Guidance—now available for download.
Biopharmaceutical equipment cleaning.
September 30, 2015 | News

New cleaning validation strategy

Presenter notes a shift to continuous monitoring to ensure effective cleaning procedures.
Pharma EXPO-PACK EXPO logo
September 30, 2015 | News

Serialization strategies

Pharma Logic Solutions presenter advises companies to think beyond U.S. requirements, and to take the time to evaluate suppliers.
Eric Bronander
September 28, 2015 | News

LIVE FROM Pharma EXPO: Compliance Lifecycle and TCO

Serialization is a program, not a process, says Innovation Stage speaker.


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