US$1.2 FDA contract for generic drug computational tool

Generics/General | Posted 16/04/2021 post-comment0 Post your comment

The US Food and Drug Administration (FDA) Office of Generic Drugs (ODG) has awarded a US$1.2 million contract to support the development of a computational tool that will aid generic drug research.

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The contract has been awarded directly to Professor Giovanni Pauletti of the University of Health Sciences and Pharmacy in St Louis (UHSP). Professor Pauletti and his research group are working on the development of a computational tool that could accelerate the development of generic forms of medications which are delivered through the oral cavity.

The contract’s funds will be used to carry out research to examining how in vitro and in silico systems can be used in conjunction with pharmacokinetic modelling in drug development. The overall aim is to develop an in silico computer modelling and simulation platform with the capability to predict drug concentrations in human subjects for generic formulations after administration to the oral cavity without the use of clinical trials. This administration route has gained interest due to its enhanced drug absorption qualities and its benefits for paediatric patients and those who are unable to swallow tablets.

Professor Pauletti hopes that, for some generics, this computational tool will remove the need for in vivo studies, which are costly in terms of time and money. Through this, patients can gain more rapid access to generic drug products.

The funds have been awarded through FDA’s OGD, which aims to provide American patients with access to safe, efficacious and high-quality generics, through rigorous science and regulation. This office has facilitated the approval of over 1,000 generic drug products to date [1]. One of the key focus areas of FDA in 2021 remains to improve access to generic drugs with the aid of the OGD [2].

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To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America.

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.



Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica.

Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa. 

1. GaBI Online - Generics and Biosimilars Initiative. Science outreach development US Generics Drugs Office reaches new highs in 2019. []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 16]. Available from: 
2. GaBI Online - Generics and Biosimilars Initiative. FDA publishes report on areas of regulatory focus for 2021. []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 16]. Available from:

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