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OTC Liquids and FDA Guidance
The subject of over-the-counter drugs is quite popular lately (see related blog post, “Using Drugs Right”), probably because of the many OTC drug recalls that have occurred in the past 18 months, and...
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The Weight of the Matter: Revising Children’s OTC Labeling
FDA may soon revise the labeling of over-the-counter pediatric medications to place a stronger emphasis on weight rather than age for dosing instructions. In mid-May, two advisory committees to the...
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A Taste Of Someone Else’s Medicine
Mistakes happen. In the pharma industry, these mistakes can lead to product recalls. Perhaps the medication is not the correct strength or maybe it became contaminated with metal fragments… …and...
View ArticleOdorous Taints Linked to Treated Wood Pallets
It is amazing what the human nose knows. Well, those who originally detected a musty, moldy odor in pharmaceutical and healthcare products didn’t know where it came from. But the odorous taints that...
View ArticleColor-Changing Sealant Technology Enhances Package Security
Rollprint Packaging Products’ new, patent-pending, color-changing sealant technology is appropriately named Chameleon; it enhances product security with a color change indicating that a pouch or tray...
View ArticlePrepare for Serialization Now
Upcoming requirements in the US and around the world for serialization and track and trace of pharmaceuticals were a focus of the Pharmapack conference held in Philadelphia, PA earlier this week....
View ArticleLiability Looms for Generic-Drug Safety Labeling Changes
FDA is proposing to revise its rules to permit generic-drug manufacturers to initiate safety-labeling changes instead of waiting until the brand company takes action. The aim of the new policy is to...
View ArticleSenate Finalizes Drug Compounding, Tracking Legislation
Congress gave final approval this week to new legislation to strengthen FDA authority to oversee large pharmacy compounders of sterile injectables and to require more comprehensive tracking of...
View ArticleDrug-Diagnostic Development Stymied by Payer Concerns
The shift to personalized medicine, which supports medical treatment tailored to individual patient characteristics, has been hindered by uncertainty over the value, accuracy, and clinical utility of...
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CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Former AstraZeneca engineer and serialization specialist, Ian Haynes, looks at the first practical step contract manufacturing organizations need to take to implement a compliance strategy ahead of the...
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