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.

March 2, 2015 | News

FDA finds problems with four sexual enhancement supplements

All four contained the same hidden ingredient, which could interact with other medications.
25 Best Healthcare Package Designs
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March 2, 2015 | News

FDA warns against hidden drug in weight loss supplement

The agency found the product contained a controlled substance that was removed from the market in October 2010 for safety reasons.
Medical devices within an operating room.
March 2, 2015 | News

Planning for a new national medical device surveillance system

New report says regulators and experts have outlined a plan for medical devices, and the patients who use them.
GlaxoSmithKline Consumer Healthcare announces the return of alli
February 25, 2015 | News

GlaxoSmithKline Consumer Healthcare announces the return of alli

Weight-loss product returns to retail markets in tamper-evident packaging.
February 19, 2015 | News

New draft documents related to compounding of human drugs issued by FDA

It includes information on drug repackaging, as well as mixing, diluting, and repackaging biological products.
February 18, 2015 | News

FDA issues guidance for repackaging

Repackaging of certain human drug products by pharmacies and outsourcing facilities contains nonbinding recommendations.
FDA issues new draft documents related to compounding of human drugs

February 13, 2015 | News

FDA issues new draft documents related to compounding of human drugs

Documents include draft guidances on outsourcing facility registration; outsourcing facility adverse event reporting; drug repackaging; mixing, diluting, and repackaging biological products; and a draft Memorandum of Understanding with the states.
INBOUND CARTONS. As cartons visible in the lower right corner are conveyed into a case packer, a camera reads all 100 unique car
February 13, 2015 | Controls Case Study

Serialization to meet Turkey’s requirements

A massive serialization project is completed in an impossibly tight timeframe by taking a modular approach across 24 packaging lines and by assembling a tight-knit team.
Panelists talk during one of the panel educational sessions at Pharmapack Europe.
February 12, 2015 | News

LIVE FROM PHARMAPACK: What will new European regulations for medical devices mean for the industry?

As a result of all the uncertainty, medical device manufacturers are left in a bit of a predicament.
February 10, 2015 | News

Hamburg’s resignation draws media reaction

FDA commissioner to step down in March, with Ostroff to serve as acting commissioner while Califf is named Deputy Commissioner for Medical Products and Tobacco.


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