Reports and Plans Mandated by FDASIA

FDASIA 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