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                Food and Drug Administration Safety and Innovation Act (FDASIA)

Food and Drug Administration Safety and Innovation Act (FDASIA)

                        FDASIA Title VII Drug Supply Chain Provisions
          FDASIA Title VII Overview
          FDASIA Section 907: Inclusion of Demographic Subgroups in Clinical Trials Home
          Regulatory Information
          Laws Enforced by FDA
          Selected Amendments to the FD&C Act
          Food and Drug Administration Safety and Innovation Act (FDASIA)
          Background on FDASIAFood and Drug Administration Safety and Innovation Act (FDASIA) Background on FDASIA
  
  	
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    PrintFact Sheets, updates, and news on FDASIA implementation.Fact SheetsReauthorization of User Fees for Prescription Drugs Will Ensure a Predictable and Efficient Human Drug Review ProgramMedical Device User Fee Amendments of 2012New User Fees for Generic Drugs Will Enhance Americansâ Access to Less Expensive Drugs and Generate Major Cost SavingsNew "Biosimilars" User Fees Will Enhance Americans' Access to Alternatives to Biologic DrugsPediatric provisions in the Food and Drug Administration Safety and Innovation Act (FDASIA)Drug Products in Shortage in the United StatesIncreased Patient Participation in Medical Product RegulationBreakthrough TherapiesResourcesFDASIA Implementation Tracking Chart (FDASIA-TRACK)Full text of the FDASIA lawBlog: User Fees: Ensuring a Stronger and Better FDA

                                                                                  Content current as of:
      03/28/2018Food and Drug Administration Safety and Innovation Act (FDASIA)

          
                        FDASIA Title VII Drug Supply Chain Provisions
          FDASIA Title VII Overview
          FDASIA Section 907: Inclusion of Demographic Subgroups in Clinical Trials
 
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