REGULATORY PRESCREENING

Standard Service …

• Names are screened for obvious sound-alike and look-alike similar drug names using specific databases per scope of work that usually include US (drugs@FDA), Europe (Article 57), and Canada (drug product database).

• Names are screened for potential promotional considerations regarding overly fanciful claims.

PLUS Services … 

• ​POCA Screening during the Creative Phase includes the name candidates will be screened using the FDA’s POCA Tool (Combined Similarity Threshold of 70%).   When used during the creative process, the output from the POCA tool is provided to the creative agency and ultimately used to help re-craft name candidates.

• Word Construction Analysis considers name similarity “beyond POCA” when reviewing cited name pairs for potential conflicts based on word construction (starting letter, prefix, suffix, number of characters, etc.).

• Percent Derivation is a tool that compares the letters/letter string of the nonproprietary name with the proposed brand name which may lead to confusion in practice among healthcare professionals.   

• SRC Stem Check is where each name candidate will be screened for USAN and/or INN stems and the evaluation includes whether the brand name appears to be derived from the nonproprietary name and whether the brand name may be confused with a common name.

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Remember SafeMark does not create brand names so we work with agencies that create names or pharmaceutical clients that have a list of names that are ready for our prescreening services!   

All PLUS PRESCREENING SERVICES are included in the Power of 3 Methodology.