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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 John Barlow “Barr” Weiner speaks to attendees of RAPS’ CGMPs for combination products workshop.
April 24, 2015 | Feature Article

FDA expresses desire to work with industry on CGMPs for combination products

RAPS event allows interaction between FDA and industry, focusing on regulatory matters for manufacturers and developers of combination products.
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PTI Inspection Systems: Package testing system
April 23, 2015 | Machine Product Brief

PTI Inspection Systems: Package testing system

The VeriPac 310 package integrity test system detects defects down to 20 microns.
Dirk Rodgers is a Contributing Editor for Healthcare Packaging and author of RxTrace.
April 23, 2015 | Column/Opinion

Four serialization and traceability predictions

In his final article, Columnist Dirk Rodgers analyzes biggest trends impacting the industry.
Eric F. Greenberg is a Contributing Editor and Legal & Regulatory columnist for Packaging World and Healthcare Packaging.
April 23, 2015 | Column/Opinion

When FDA is a cop

A quick, effective response to FDA can prevent serious consequences.
April 21, 2015 | News

Packaging, labeling play role in lawsuits

Plaintiffs file lawsuits alleging misleading labeling and packaging for Pfizer’s Advil and KAO USA’s Ban products.
Specialty pharmacies, says at least one group, represent the fastest-growing segment of the pharmaceutical market.
April 10, 2015 | News

Promising future for specialty pharmacies

Taking a quick look at the market and the challenges in what at least one group says represents the fastest-growing segment of the pharmaceutical market.
April 9, 2015 | News

Fast-tracking medical devices through the FDA

Starting April 14, the new program will help manufacturers of devices for life-threatening, or irreversibly debilitating, conditions get approval faster.
April 8, 2015 | News

Is lack of standardized medical device labeling harming patients?

The FDA is studying if they should require standardized medical device labeling.
April 7, 2015 | News

Near record lows for medical device recalls

It's been two years since the FDA saw recall numbers this low.
FDA issues final guidance on the evaluation and labeling of abuse-deterrent opioids
April 1, 2015 | News

FDA issues final guidance on the evaluation and labeling of abuse-deterrent opioids

The U.S. Food and Drug Administration on April 1, 2015 issued a final guidance to assist industry in developing opioid drug products with potentially abuse-deterrent properties.

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