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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.

The European Medicines Agency EMA is a decentralized agency of the European Union, located in London. The agency is responsible
May 22, 2015 | News

EMA revises fixed combination product guideline

Covers clinical development requirements for fixed combination products—open for consultation until Nov. 15, 2015.
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May 21, 2015 | News

FDA proposes change in antimicrobials reporting

The new data collected would be used to help target its efforts to ensure judicious use of medically important antimicrobials.
May 7, 2015 | News

New drug, biologic FDA fillings will only be done electronically

Is print dead? Maybe, if you are looking to file something with the FDA.
HealthPack 2016 will be held March 15-17 at the Astor Crowne Plaza in New Orleans.
May 5, 2015 | Feature Article

Medical device packaging takes center stage at HealthPack

HealthPack 2015 focused on exclusive survey and package design. Meanwhile HealthPack 2016 venue is established.
Severe weather and biological products
May 4, 2015 | Primer

Severe weather and biological products

CBER offers information on how to handle temperature-sensitive biologics in power outages or floods.
April 29, 2015 | News

FDA cracks down on supplements containing DMBA

The 14 warning letters sent by the agency address 17 products that contain the ingredient.
Contract development and manufacturing organization completes first commercial serialization project for South Korea.
April 28, 2015 | News

Serialization first in South Korea

Contract development and manufacturing organization delivers identifiable labeling for a top-10 pharmaceutical company.
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.
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.

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