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 In this section:

        Development & Approval Process | Drugs

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
          Drug Interactions & Labeling
          Labeling Information | Drug Products Home
          Drugs
          Development & Approval Process | Drugs
          Development ResourcesDevelopment & Approval Process | Drugs Development Resources
  	
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    PrintFDA encourages sponsors to communicate with us well before they propose clinical trials for new drugs, especially for serious diseases, rare diseases, pediatric conditions, and those for which there are limited or poor treatment options. FDA determines whether the drug is safe enough to test in humans and, if so--after all human testing is completed--decides whether the drug can be sold to the public.

Surrogate Endpoints
	Manual of Policies & Procedures (CDER)

                                                                                  Content current as of:
      08/29/2018Development 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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