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PDA revises report on glass container manufacturing

European Pharmaceutical Review

The long-awaited PDA TR 43 report provides an approach to a quality decision-making process and represents best practices for the identification and classification of visual nonconformities for (empty) glass containers as pharmaceutical product packaging.

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Purdue to pay $8.3bn after admitting criminal charges in opioid case

pharmaphorum

Purdue filed for bankruptcy last year, after it proposed a separate $10 to $12 billion settlement package to resolve those lawsuits. It admitted to bribing two doctors to write more prescriptions of OxyContin as well as other drugs between June 2009 and March 2017. Image by Gerd Altmann from Pixabay.

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Drugs and Lactation

RX Note

In the past, package inserts were not always reliable sources of information regarding medication safety during lactation. Notable exceptions are heparin and insulin which are too large to cross biological membranes. As a general rule, breastfeeding is considered acceptable when the relative infant dose is <10%.

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Digital investment promises to accelerate the use of wearable sensor data in clinical trials

pharmaphorum

Garabedian and his team plan to support VivoSense, not just with their funding package but with their industry network and connectivity. “We He served as the President and CEO of Sarepta Therapeutics from 2011 to 2015 and led corporate strategy for Celgene from 2007 to 2010 ( see more on LinkedIn ). This brings us to VivoSense.

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Medication Safety

RX Note

Such events may be related to professional practice and healthcare products, procedures and systems, including prescribing; order communication; product labelling, packaging and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.

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Eye Preparations

RX Note

A double-masked conjunctival allergen challenge (CAC) study in 2007 found no significant difference in the mean itching scores between two drops of olopatadine 0.1% (Patanol) and one drop of olopatadine 0.2% (Pataday). The packaging of Systane Ultra now writes: discard any remaining solution SIX months after first opening.

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The lingering menace of diethylene glycol / ethylene glycol adulteration

European Pharmaceutical Review

There is now global awareness of this issue and FDA issued a guidance note on the problem in 2007. Tamper‑evident packaging is also recommended to prevent adulteration or contamination of the excipient. Pharmacopoeia guidance on DEG and EG. 3 Furthermore, the European Commission (EC) stated that “up to 0.1% Ann Intern Med.