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Antibacterial Drug Development Task Force
The CDER Antibacterial Drug Development Task Force has been created to support the development of new antibacterial drugs. This multi-disciplinary group, comprised of scientists and clinicians from throughout CDER, will work with other experts from academia, regulated industry, professional societies, patient advocacy groups, and government agencies to jointly promote antibacterial drug development.
The goals of the task force are to:
Explore novel scientific approaches to facilitate antibacterial drug development, such as the broader use of clinical pharmacology data, Bayesian methods, innovative clinical trial designs, utilization of additional available data sources, and the advancement of alternative measures to evaluate clinical effectiveness of potential new therapies.
Identify issues related to unmet medical needs for antibacterial drugs, reasons for the lack of a robust pipeline for antibacterial drug development, and new approaches for weighing the risks, benefits, and uncertainties of potential new antibacterial drugs.
Evaluate existing FDA guidances related to antibacterial drug development, determine if revision or further elaboration is needed, and identify areas where future guidance would be helpful.
Participate in think tanks with other thought leaders to address various issues that could enable antibacterial drug development, including study design, statistical analytical methods, and approval pathways.
- Task Force Members
Antibacterial Task Force: How CDER is establishing and promoting new approaches to antibacterial drug development New FDA task force will support innovation in antibacterial drug development
FDA news release (9/24/2012)
New Approaches to Antibacterial Drug Development; Request for Comments
Federal Register notice (5/31/2013)
Modernizing Antibacterial Drug Development, Brookings Institution – February 7, 2014 CTTI Workshop on Optimizing Operational Efficiencies for Data Collection in HABP/VABP Trials – November 12, 2013 CTTI Antibacterial Drug Development Working Group Webinar - August 29, 2013 Special Medical Use: Limited Use for Drugs Developed in an Expedited Manner to Meet an Unmet Medical Need, Brookings Institution – August 1, 2013 CTTI Workshop on Antibacterial Drug Development: Developing a Pilot Protocol for Hospital Acquired and Ventilator Associated Bacterial Pneumonia - April 22-23, 2013 Brookings Council on Antibacterial Drug Development Meeting #2 – February 27, 2013
- Public Hearing: Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need - February 4, 2013
CTTI Workshop on Innovation in Antibacterial Drug Development - October 11-12, 2012 Brookings Council on Antibacterial Drug Development Meeting #1 - August 30, 2012 CTTI Workshop on Statistical Issues of Antibacterial Drug Development – August 20, 2012
- Facilitating Antibacterial Drug Development, Brookings Institution - May 9, 2012