FDA announces the Request for Information (RFI), “Development of New Antibacterial Drugs Active Against Multi-Drug Resistant Bacteria.”- Drug Information Update

FDA is announcing the Request for Information (RFI), “Development of New Antibacterial Drugs Active Against Multi-Drug Resistant Bacteria.”  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) to obtain external input into developing an annual list of regulatory science initiatives specific for antimicrobial products.

This RFI seeks research ideas to identify research areas where regulatory science can support new antibacterial drug development in general, by creating new drug development tools or standards for use by industry or other stakeholders, to meet patient needs. FDA is exploring approaches to help stimulate development programs for antibacterial drugs where limited resources or a lack of incentives is preventing the development of new antibacterial drugs.

Antibacterial drug resistance is a major threat to public health. The design and conduct of clinical trials to evaluate new antibacterial drugs in patients with serious bacterial infections is challenging. Recruitment can be difficult because there is a need to immediately begin antibacterial drug treatment. There is often a delay in availability of information regarding the identification and antibacterial susceptibility of the causal pathogen, when isolated. Innovative scientific approaches can help facilitate new drug development as part of efforts to combat antibacterial drug resistance. Given the increased prevalence of antibiotic resistant bacterial infections, it is important for the public health community to focus efforts in this realm of research.

  

Responses to the RFI will be accepted until October 31, 2018.

Please find additional information at: Request for Information (RFI), “Development of New Antibacterial Drugs Active Against Multi-Drug Resistant Bacteria.”