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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.

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.
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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.
PHARMALINK 2015. Ellen Morrison, Assistant Commissioner, FDA (left), and Marla Phillips, Director, Xavier Health, welcomed 185 a
March 30, 2015 | News

FDA’s pharmaceutical quality focus continues to expand globally

PharmaLink 2015: With more products imported into the U.S. from more countries around the world, the focus must remain on patient safety and health outcomes.
DENTAL DEVICE. EMS’s Piezon® 250 is a compact ultrasonic dental scaler that offers precise power and irrigation control.
March 27, 2015 | Feature Article

Medical device maker wins with enterprise labeling system

Switzerland-based Electro Medical Systems meets UDI regulations, reduces mislabeling, and improves print performance.
March 25, 2015 | News

Does the FDA's system for approving medical devices work?

That was one of the question the Wall Street Journal posed to three experts, including a former FDA deputy commissioner.
Dirk Rodgers is a Contributing Editor for Healthcare Packaging and author of RxTrace.
March 20, 2015 | Column/Opinion

Interoperability and the DSCSA

Defining the terminology will be half the FDA's battle.
Eric F. Greenberg is a Contributing Editor and Legal & Regulatory columnist for Packaging World and Healthcare Packaging.
March 19, 2015 | Column/Opinion

FDA's Hamburg's resignation

She served almost six years, juggled the agency’s varied responsibilities effectively, and her successor will continue to face varied challenges.

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