For over 30 years, Brand Institute has led more FDA proprietary name approvals than any other agency in the world — backed by former FDA naming officials who co-authored the agency's name review guidelines. We hold an 88% share of FDA Rx name approvals.
Former FDA naming officialsUSAN/INN strategyProprietary name developmentLASA safety screeningNDA / BLA submissionsFMEA analysis
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FDA INSIDERBrand Institute's regulatory subsidiary, Drug Safety Institute (DSI), is staffed by former FDA naming officials who co-authored the FDA proprietary name review guidance — the same documents your submission is evaluated against.
CREDENTIALS
Former FDA naming officials
Co-authored FDA name review guidelines
88% FDA Rx name approval share
5,000+ names developed
1,500+ pharma partners
FDA submission expertise
Every FDA naming pathway, covered
Whether you're filing an NDA, BLA, or OTC application — or developing a USAN nonproprietary name — our former FDA officials navigate the full naming lifecycle.
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NDA / BLA
Proprietary name development
FDA-compliant proprietary (brand) name development, LASA safety analysis, medication error risk assessment, and full submission dossier — prepared by former FDA officials.
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USAN / INN
Nonproprietary naming strategy
USAN application strategy, INN alignment, stem selection, and AMA Council advisory guidance. The most complex naming step — handled by the team that wrote the rules.
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OTC branding
Over-the-counter brand naming
OTC brand name development with FDA OTC monograph compliance. Consumer research, retail shelf impact testing, and LASA review for consumer medication safety.
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Biologics
Biosimilar & biologic naming
4-letter suffix strategy for FDA biosimilar naming, interchangeability designations, and 351(a)/(k) pathway naming — including complex biologic LASA analysis.
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Medical devices
Medical device naming
510(k) and PMA device name development. FDA device naming conventions, trademark clearance via USPTO, and brand strategy for Class II / III devices.
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Clinical trials
IND-stage trial naming
Protocol-stage naming protects your commercial launch. IND application naming strategy that sets up a smooth NDA/BLA proprietary name submission later.
USAN / INN expertise
The USAN advantage no other agency offers
Former AMA naming leaders. Former WHO naming advisors.
USAN (United States Adopted Name) selection is one of the most complex and consequential steps in drug development — and one that most naming agencies get wrong. Brand Institute's Drug Safety Institute includes former leaders from naming divisions at the AMA and WHO, alongside former FDA, EMA, and Health Canada officials — the same regulatory community that shapes the global nonproprietary naming system.
✓USAN application filing and negotiation with the AMA Council
✓INN submission to WHO — internationally harmonized naming
✓Stem strategy (selecting the right pharmacological suffix)
✓USAN/INN safety analysis — preventing confusion with existing names
✓Class name and modifier strategy for drug families
✓Nonproprietary name development for novel drug classes
We name drugs across every therapeutic area and FDA submission type — from first-in-class biologics to OTC reformulations.
Oncology
mAbs, ADCs, small molecules, CAR-T, checkpoint inhibitors