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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 growing global focus faces language barriers
September 11, 2014 | Column/Opinion

FDA’s growing global focus faces language barriers

As FDA becomes more globally focused, drug complaints and adverse event reporting pose “cultural” challenges, as do inspections.
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PDA developing Technical Report on drug shortages
September 10, 2014 | News

PDA developing Technical Report on drug shortages

Parenteral Drug Assn. expects to publish report on the prevention and management of drug shortages by early 2015.
Healthcare Packaging Publisher Jim Chrzan.
September 9, 2014 | News

FDA continues to stress manufacturing excellence

PDA/FDA Joint Regulatory Conference says global supply chain will require unprecedented cooperation.
Desmond Hunt, Ph.D., Senior Scientific Liaison, U.S. Pharmacopeial Convention (USP)
September 8, 2014 | Column/Opinion

USP to roll out information chapters on Good Distribution Practices

Five new general chapter standards related to GDP to become official next year, when three new chapters will be proposed.
PDA’s Universe of Pre-filled Syringes & Injection Devices Conference and Exhibition will be held October 6-7 at the Hyatt Regency Huntington Beach, CA. The exhibit hall will be open from 9:45 a.m. to 4:00 p.m. on Monday, Oct. 6, and from 9:45 a.m. to 4:00 p.m. on Tuesday, Oct. 7. For more information, contact PDA at 301/656-5900.
September 4, 2014 | News

Universe of pre-filled syringes and injection devices

Parenteral Drug Assn. conference and exhibition features top packaging companies.
September 3, 2014 | News

Report: 19 million Americans abuse prescription drugs

Novus Medical Detox believes that more education is needed. Can packaging play a role in reducing prescription drug abuse?
Dirk Rodgers, who contributed to Healthcare Packaging’s Pharmaceutical Serialization Playbook, is an independent consultant and founder of RxTrace.
August 29, 2014 | Column/Opinion

The case for and against RFID in pharma

Reaching necessary read accuracies remains a challenge in pharmaceuticals, but RFID could still prove useful.
Eric F. Greenberg is a Contributing Editor and Legal & Regulatory columnist for Packaging World and Healthcare Packaging.
August 27, 2014 | Column/Opinion

Packaging leads to CPSC action

Commission says some Dr. Reddy’s packaging failed to meet ‘special packaging’ that is resistant to children but openable by adults.
MJS Packaging: Bottles
August 27, 2014 | Materials Product Brief

MJS Packaging: Bottles

New bottles for nasal market support changing child-resistant packaging requirements.
Dr. Michael Drues is president of Grafton, MA-based Vascular Sciences (www.vascularsci.com), an education, training, and consulting company. He can be reached on Linkedin®, by phone at 508.887.9486, and by e-mail at mdrues@vascularsci.com
August 25, 2014 | Column/Opinion

The Future of Medicine: Biomedical nanotechnology

The smaller the thing, the bigger the challenge for nanotechnology, for medical treatment, for packaging, and for regulatory.

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