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 In this section:

                Development Resources

Development Resources

                        Advancing Real-World Evidence Program
          Antibacterial Drug Development Task Force
          BEST Resource Taxonomy
          Clinical Outcome Assessment Compendium
          Complex Innovative Trial Design Meeting Program
          Division of Pediatric and Maternal Health
          FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria
          Ingredients
          Medical Imaging and Drug Development
          Rare Disease Endpoint Advancement Pilot Program
          Split Real Time Application Review (STAR)
          Surrogate Endpoint Resources for Drug and Biologic Development
          Model-Informed Drug Development Paired Meeting Program
          MIDD Paired Meeting Program Frequently Asked Questions


                        Cancer Drugs
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          Development Resources
          Antibacterial Drug Development Task ForceDevelopment Resources Antibacterial Drug Development Task Force
  
  	
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    PrintThe 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.Additional Information

Task Force Members
	New Approaches to Antibacterial Drug Development; Request for CommentsActivities

Modernizing Antibacterial Drug Development, Brookings Institution - February 7, 2014
	Special Medical Use: Limited Use for Drugs Developed in an Expedited Manner to Meet an Unmet Medical Need, Brookings Institution - August 1, 2013
	Brookings Council on Antibacterial Drug Development Meeting #2 - February 27, 2013
	CTTI Workshop on Innovation in Antibacterial Drug Development - October 11-12, 2012
	Brookings Council on Antibacterial Drug Development Meeting #1 - August 30, 2012
	Facilitating Antibacterial Drug Development, Brookings Institution - May 9, 2012

                                                                                  Content current as of:
      02/26/2021Development Resources

          
                        Advancing Real-World Evidence Program
          Antibacterial Drug Development Task Force
          BEST Resource Taxonomy
          Clinical Outcome Assessment Compendium
          Complex Innovative Trial Design Meeting Program
          Division of Pediatric and Maternal Health
          FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria
          Ingredients
          Medical Imaging and Drug Development
          Rare Disease Endpoint Advancement Pilot Program
          Split Real Time Application Review (STAR)
          Surrogate Endpoint Resources for Drug and Biologic Development
          Model-Informed Drug Development Paired Meeting Program
          MIDD Paired Meeting Program Frequently Asked Questions


                        Cancer Drugs
          Drug Interactions & Labeling
          Labeling Information | Drug Products
 
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