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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.

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.
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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.
Global Data forecast sees significant U.S. pharmaceutical market growth
March 17, 2015 | News

Forecast sees significant U.S. pharmaceutical market growth

The Patient Protection and Affordable Care Act, faster FDA product approvals, and millions of previously uninsured people potentially entering the patient pool expected to help drive future pharmaceutical growth.
March 11, 2015 | News

Packaging company CEO slams FDA over drug labeling

Eliminating printed professional inserts would put pharmacies at risk, the CEO believes.
March 9, 2015 | News

FDA requires new labeling on testosterone products

In addition manufactures must also conduct a clinical trial to address new concerns over increase risk for heart problems.
HealthPack 2015 Survey
March 5, 2015 | Feature Article

HealthPack audience members compare themselves with their peers around the world

Healthcare Packaging Team presents new, exclusive demographic research from 110 medical device packagers.
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.

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