Brandsymbol’s Dyan Rowe Davis Shares Regulatory Insights at NRG meeting for the EMA

President of Brandsymbol’s Regulatory Division breaks down FDA’s 50% similarity rule and EMA’s INN decision tree in back-to-back global presentations.

CHARLOTTE, NC, UNITED STATES, July 31, 2025 /EINPresswire.com/ -- Brandsymbol, a global leader in pharmaceutical brand naming, proudly highlights two recent, pivotal presentations by Dyan Rowe Davis, B.S. Pharm., R.Ph., J.D., President of Brandsymbol’s Regulatory Division. These talks addressed evolving regulatory challenges across both the U.S. and European drug name review processes.

At the 2025 NRG Interested Parties Meeting, Dyan shared a detailed analysis of the FDA’s “50% similarity” rule, a benchmark historically used to evaluate potential name confusion. Her presentation underscored the limitations of this guideline in a modern landscape increasingly influenced by AI. Notably, Dyan explored:

Why the 50% similarity rule isn't always clear-cut.

How “common letters” often include phonetic and INN root overlaps, not just visual similarities.

Complexities like “skip letters” and multi-path interpretation scenarios that confuse regulators and industry stakeholders alike.

📥 Download the full NRG presentation deck.

Despite the rise of algorithmic screening tools, Davis emphasized the continued importance of human regulatory expertise in safeguarding patient safety. “AI is a powerful partner, but not a substitute for judgment,” she noted.

At the 2025 EMA Interested Parties Meeting, Dyan turned her focus to INN similarity within the EU, delivering an exclusive presentation titled Understanding INN Similarity: Clarifying the EMA’s Decision-Making Criteria. She broke down the EMA’s internal Similarity with the INN Decision Tree and revealed behind-the-scenes insights from current naming evaluations.

These sessions reaffirmed Brandsymbol’s position as a global leader at the intersection of pharmaceutical branding and regulatory insight. As tools like the MOSAIQ™ AI Platform redefine how names are screened, Brandsymbol remains committed to balancing innovation with compliance.

About Brandsymbol
Brandsymbol is a global branding and naming agency renowned for developing strategic, compliant, and impactful pharmaceutical brand names. With deep domain expertise spanning creative development, trademark law, and global regulatory standards, Brandsymbol partners with the world’s top companies to create brand names that perform across markets.
🌐 https://brandsymbol.com

Emilie Tolley
Brandsymbol
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