Will your proposed drug name stand up to FDA scrutiny?

The FDA’s recently released naming guidance has several key additions and changes you must understand when developing names. Failure to follow the guidelines could create confusion and lead to medication errors.

No one test or standard is adequate to determine whether a proposed name might contribute to medication errors. The FDA advocates the use of a combination of different, complementary tests to identify and remedy potential sound-alike and look-alike confusion with existing drug names.

Fortunately, Susan M. Proulx, PharmD, Managing Director, Drug Safety at Leaderboard Branding, is an international leader in preventing medication errors due to brand name confusion. She’ll explain the FDA’s current thinking on best practices for developing and selecting proposed proprietary names.

Webinar Takeaways:

• How the prescreening process relates to attributes that may contribute to medication errors in naming drugs
• Suggested methods of evaluating the risk of medication errors related to naming
• The FDA process for notifying applicants that have similar names in the FDA queue
• The phonetic and orthographic computer analysis (POCA) criteria and its use in evaluating name similarity
• The FDA-suggested process for evaluating promotional aspects of a proprietary name
• The tasks necessary for conducting name simulation studies