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Choosing the Right Drug Name: Increase Your Chances for Approval by FDA and Health Canada
While the FDA rejection rate has decreased in recent years, it is still high enough to cause anxiety when getting a product approved.
Not surprisingly, the drug industry has criticized the agency about its name approval process and has asked for them to provide feedback.
So, in May 2014, the FDA released a draft guidance that covers the selection and approval process for proposed names of both prescription and nonprescription human drugs and biologics.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.
In addition, Health Canada issued their final guidance, "Review of Drug Brand Names" on June 13, 2015. This requires companies now to follow a process which is much more prescriptive, time-consuming and costly.
FDAnews has teamed with drug-naming expert Dr. Susan Proulx to present a 90-minute webinar that will look closely at both guidances. Dr. Proulx will provide ideas on how to win approval for your suggested drug name.
BONUS HANDOUT: Attendees will receive their own copy of a chart that compares drug name approval regulations in the US and Canada.
And you'll learn more about the following:
Choosing the Right Drug Name: Increase Your Chances for Approval by FDA and Health Canada is sure to be a presentation you won't want to miss.
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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