martes, 24 de enero de 2017

Developing Animal Models for Infection: Request for Information

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

FDA is announcing the Request for Information (RFI), ‘Developing Animal Models for Infection.”  The purpose of this RFI is to solicit informal input from the public and private sectors (e.g. industry, academia, Federally Funded Research and Development Centers (FFRDCs), government laboratories, physician and pharmacist societies, patient-focused research foundations and advocacy groups, and other health care providers).
This RFI seeks research ideas to facilitate the development of antibacterial drugs to address patient needs, including new drugs that are active against bacteria resistant to many currently available therapies. FDA is interested in research to advance regulatory science to facilitate the development of narrow-spectrum antibacterial drugs such as those that are active against only a single species of bacteria that may not occur frequently in any one type of infection/site of infection.  When the species occurs infrequently, performing clinical trials can be extremely challenging.  Therefore, animal models of infection may be useful to explore the activity of a candidate antibacterial drug and may help to predict the likelihood of human clinical response.   Additional scientific work to evaluate the current state of animal models of infection and evaluate potential animal models that may predict response in humans could advance the development of antibacterial drugs targeting a single species.
Responses to the RFI will be accepted until February 1, 2017.
Please find additional information at: Animal Models for Infection

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