Choosing the Right Drug Name - Webinar CD/Transcript
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So, in May 2014, the FDA released a draft guidance that covers the selection and approval process for proposed names of both prescription and nonprescription human drugs and biologics.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 Susan Proulx to look closely at the draft guidance and its recommended 4-step process.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:
- How the new guidance will impact on drug trademark development (in time, money, and the differences from country to country that affect processing for a global mark)
- Pros and cons of relying on computerized searching to identify similarity in proposed names
- Using simulation testing — how to conduct testing similar to what the FDA will eventually do on your chosen drug name
- The need for expert analysis before you decide what trademark to choose
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.