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 In this section:

                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)
          Reports and Plans Mandated by FDASIAFood and Drug Administration Safety and Innovation Act (FDASIA) Reports and Plans Mandated by FDASIA
  
  	
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    PrintFDASIA requires FDA to develop several different kinds of informational documents, including public reports, reports to Congress, strategic plans, communications plans, and others. FDA will post those items here as they become available.

FDASIA Reports

FY 2015-2016: Regulatory Science Progress Report
	FY2013-FY2014 Regulatory Science Progress Report
	Complex Issues in Developing Drugs and Biological Products for Rare Diseases and Accelerating the Development of Therapies for Pediatric Rare Diseases; Including Strategic Plan: Accelerating the Development of Therapies for Pediatric Rare Diseases
	2015 Annual Report on Inspections of Establishments
	Collection, Analysis, and Availability of Demographic Subgroup Data for FDA-Approved Medical Products
	FDA Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data
	Review of Federal Drug Regulations With Regard to Medical Gases
	Regulatory Science Strategy and Implementation Plan for Medical Products
	FDASIA Section 1125 IT Report to Congress
	Small Business Report
	Integrated Strategic Management Plan for Medical Product Centers
	Sec. 1138: Ensuring Access to Adequate Information on Medical Products for All
	2016 Annual Report on Inspections of Establishments in FY 2015
	2017 Annual Report on Inspections of Establishments in FY 2016

                                                                                  Content current as of:
      01/19/2024Food 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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