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                Development & Approval Process | Drugs

Development & Approval Process | Drugs

                        Clinical Data Summary Pilot Program
          Drug Development Tools | DDTs
          Guidance Documents for Drug Applications
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          Pilot Program for the Review of Innovation and Modernization of Excipients (PRIME)


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          Drugs
          Development & Approval Process | Drugs
          Financial Transparency And EfficiencyDevelopment & Approval Process | Drugs Financial Transparency And Efficiency
  
  	
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    PrintFDA is committed to ensuring user fee resources are administered, allocated, and reported in an efficient and transparent manner. Under PDUFA VI, BsUFA II, and GDUFA II, FDA committed to conducting activities to evaluate the financial administration of these user fee programs to help identify areas to enhance efficiency. FDA also committed to conduct activities to enhance transparency of PDUFA, BsUFA, and GDUFA program resources. These commitments included contracting with an independent third part to conduct an evaluation of PDUFA, BsUFA, and GDUFA program resource management during FY 2018, publishing five-year financial plans for these user fee programs, and convening a public meeting during the third quarter of each fiscal year (starting in FY 2019) to discuss topics related to program resource and financial management.

PDUFA, BsUFA, and GDUFA Five-Year Financial Plans

Annual Public Meeting:  Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments, June 18, 2021. The meeting will be held virtually by Webcast Link.

Fiscal Year 2018 Financial Management Evaluation for Human Drug User Fees Assessment Report

                                                                                  Content current as of:
      05/04/2021Development & Approval Process | Drugs

          
                        Clinical Data Summary Pilot Program
          Drug Development Tools | DDTs
          Guidance Documents for Drug Applications
          Laws, Regulations, Policies and Procedures for Drug Applications
          Pilot Program for the Review of Innovation and Modernization of Excipients (PRIME)


                        Drug Development Tool (DDT) Qualification Programs
          CDER Small Business & Industry Assistance (SBIA)
          Conducting Clinical Trials
          Development Resources
          Drug Approvals and Databases
          Forms & Submission Requirements
          How Drugs are Developed and Approved
          New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products
          Pharmaceutical Quality Resources
 
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