Medically-Based Enterprise Risk Management
Pharmaceuticals
Pharmaceutical Class Labeling
Challenge:
Prescription medication inserts varied, according to the practice of individual pharmaceutical companies. The USFDA hired us to develop uniform labeling for prescription medications in common classes of drugs.
Solution:
We researched literature and existing labels and developed a single drug insert for thirteen classes of drugs (with variations for the specific agents). This was the first time that uniformity of pharmaceutical package inserts had ever taken place. It is now the standard.
Reflection:
Our ability to cull relevant, essential medical / scientific information from volumes of literature and other source documents resulted in an end product for our client that set the standard for an enduring industry practice.
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