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Choosing the Right Drug Name: How to Increase Your Chances for Approval
The FDA rejects 40% of the drug names presented to it each year.
Not surprisingly, the drug industry has long criticized the agency about its name approval process.
So, in May 2014, the FDA released a draft guidance that covers the selection and approval process for proposed names of both prescription and nonprescription human drugs and biologics. In the guidance, the FDA describes its own review processes in detail and lays out 4 steps your company should follow in choosing a drug name.
To address this issue, FDAnews teamed with drug-naming expert Dr. Susan Proulx to look closely at the draft guidance and its recommended 4-step process. Dr. Proulx provides ideas on how to win the FDA’s approval for your suggested drug name.
And you'll learn more about the following:
You don’t want to miss the CD and transcript of the Choosing the Right Drug Name: How to Increase Your Chances for Approval webinar.
Over the course of her career in Medication Safety, Dr. Susan Proulx has become an expert in all aspects of product-related safety issues. In addition to being a leader in the industry in preventing medication errors due to trademark confusion, she also has overseen numerous projects related to improvement of packaging and labels to increase clarity and ease of reading.
In recent years, Dr. Proulx has lent her medication safety expertise to the field of Human Factors Engineering, collaborating on label safety and drug-device usability issues. Some of these projects have led to patents and publications.
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