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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.

Map of India
August 14, 2014 | Feature Article

An insider’s look at the healthcare market in India

The latest on India’s pharmaceutical and medical device markets, with a perspective from Vimal Kumar, Senior Specialist and Head Solutions/Medical Electronics for Tata Elxsi, a design engineering service provider in Pune, India.
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Update on findings in the FDA cold storage area on the NIH campus. This photo for illustrative purposes only.
July 17, 2014 | News

Update on findings in the FDA cold storage area on the NIH campus

'Well-packed' samples of biological agents believed to have been assembled between 1946 and 1964 were shipped to a Homeland Security Center for safeguarding.
July 17, 2014 | Supplier News

FDA MedWatch - June 2014 safety labeling changes includes 52 products with revisions to prescribing information

The MedWatch June 2014 Safety Labeling Changes posting includes 37 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.
Dirk Rodgers, who contributed to Healthcare Packaging’s Pharmaceutical Serialization Playbook, is an independent consultant and founder of RxTrace.
July 9, 2014 | Column/Opinion

Congress should have mandated randomization

Congress should have mandated randomization of drug serial numbers, but they did not, so it is up to each manufacturer to recognize the importance it would bring to the protection of their brands and of the supply chain.
FDA outlines expectations for human drug compounders
July 8, 2014 | News

FDA outlines expectations for human drug compounders

Agency says this includes registered outsourcing facilities; offers multiple documents via web links included herein.
July 3, 2014 | Supplier News

Federal judge approves consent decree with New York dietary supplement maker

Mira Health Products manufactured and distributed unapproved and adulterated products
July 3, 2014 | Supplier News

FDA MedWatch - Coumadin

Coumadin (warfarin sodium) for Injection by Bristol-Myers Squibb: Recall - Particulate Matter
July 3, 2014 | Supplier News

FDA seeks permanent injunction against California pharmaceutical company

On June 25, the U.S. Department of Justice, at the request of the U.S. Food and Drug Administration, filed a complaint for permanent injunction in the U.S. District Court for the Central District of California against Laclede, Inc. (Laclede) of Rancho Dominguez, California, and its president, Michael A. Pellico.
Eric F. Greenberg is a Contributing Editor and Legal & Regulatory columnist for Packaging World and Healthcare Packaging.
July 2, 2014 | Column/Opinion

Tanning product order colors understanding of law

Shedding light on how and why FDA can regulate sunlamp products.
GlobalData report says patent expirations of branded biologics and regulatory changes will help biosimilars gain market share from biologics.
June 12, 2014 | News

Biosimilars to erode biologics market beyond 2019

GlobalData report says patent expirations of branded biologics and regulatory changes will help biosimilars gain market share from biologics.

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