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Original Research

Pre-ANDA strategy and Human Factors activities to de-risk pharmaceutical companies ANDA submission of drug–device combination products: case study of a formative Comparative Use Human Factors study

Laurie Brunet-Manquata BD Medical - Pharmaceutical Systems, Becton Dickinson and Company, Le Pont-de-Claix, FranceView further author information
,
Anne Combedazoua BD Medical - Pharmaceutical Systems, Becton Dickinson and Company, Le Pont-de-Claix, FranceCorrespondence[email protected]
View further author information
,
Bomby Ahujab BD Medical - Pharmaceutical Systems, Becton, Dickinson and Company, Franklin Lakes, NJ, USAView further author information
,
Alice Madena BD Medical - Pharmaceutical Systems, Becton Dickinson and Company, Le Pont-de-Claix, FranceView further author information
,
Claire Ramusa BD Medical - Pharmaceutical Systems, Becton Dickinson and Company, Le Pont-de-Claix, FranceView further author information
,
Tatsiana Mardovinab BD Medical - Pharmaceutical Systems, Becton, Dickinson and Company, Franklin Lakes, NJ, USAView further author information
&
Cécile Froleta BD Medical - Pharmaceutical Systems, Becton Dickinson and Company, Le Pont-de-Claix, FranceView further author information
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Received 21 Mar 2024, Accepted 01 May 2024, Published online: 29 May 2024

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