Regulatory

Update on findings in the FDA cold storage area on the NIH campus. This photo for illustrative purposes only.
News
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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.
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Dirk Rodgers, who contributed to Healthcare Packaging’s Pharmaceutical Serialization Playbook, is an independent consultant and founder of RxTrace.
Column/Opinion
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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
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FDA outlines expectations for human drug compounders

Agency says this includes registered outsourcing facilities; offers multiple documents via web links included herein.
Eric F. Greenberg is a Contributing Editor and Legal & Regulatory columnist for Packaging World and Healthcare Packaging.
Column/Opinion
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Tanning product order colors understanding of law

Shedding light on how and why FDA can regulate sunlamp products.
Column/Opinion
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Pondering packaging possibilities for pot products

There are so many surprising, fascinating aspects of the rapidly disintegrating illegality of marijuana in America.
GlobalData report says patent expirations of branded biologics and regulatory changes will help biosimilars gain market share from biologics.
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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.
UK-based Child Safe Packaging Group notes that by 2015, the need for child-resistant packs will increase, and more package testing may be required.
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Forthcoming CLP regs expected to increase need for child-resistant packaging

UK-based Child Safe Packaging Group notes that by 2015, the need for child-resistant packs will increase, and more package testing may be required.
USP to focus on the topics of Good Distribution Practices (GDPs) for pharmaceuticals, quality management systems, environmental conditions management, importation/exportation management, and supply chain integrity and security issues.
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USP needs input from pharma industry experts: Mary Foster

USP to focus on the topics of Good Distribution Practices (GDPs) for pharmaceuticals, quality management systems, environmental conditions management, importation/exportation management, and supply chain integrity and security issues.
Column/Opinion
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Food reports still here, getting tougher

Let’s say you package food, and you suspect contamination of food by dangerous bacteria has occurred.
News
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Kashi formulas or labels likely to change by end of year

The Kellogg Company agrees to drop the terms “all natural” and “nothing artificial” from some Kashi products.

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