Reports on Agency Policies and Initiatives

Reports to inform the public of the FDA's policies, procedures, and initiatives to improve its regulatory processes, foster innovation in medical products and research, and advance public health protection.

Reports issued more than 2 years ago may be found in the FDA.gov Archive

Reports

• 11/2024: Best Practices for FDA Communication with Interested Parties: Draft Report for Public Comment
• 11/2024: Food and Drug Administration Report and Plan on Best Practices for Guidance
• 03/2024: Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together
• 01/2024: Strategic Workforce Plan FY 2023 to 2027
• 12/2023: Food and Drug Administration’s Draft Report and Plan on Best Practices for Guidance
• 02/2023: Medical Countermeasures Initiative (MCMi) FY 2022 Program Update report 
• 11/2022: FDA-USPTO Collaboration Initiatives
• 08/2022: FDA's Work to Combat the COVID-19 Pandemic
• 03/2022: Modernization in Action 2022
• 01/2022: FDA 2021 Year in Review - Working for You
• 11/2021: An Update to the Resiliency Roadmap for FDA Inspectional Oversight
• 11/2021: Marketing of First Generic Drugs Approved by U.S. FDA from January 2010 to June 2017
• 09/2021: FDA Letter to U.S. Patent and Trademark Office Pursuant to Executive Order 14036
• 06/2021: Executive Order 14017 on America’s Supply Chains
• 05/2021: Resiliency Roadmap for FDA Inspectional Oversight
• 01/2021: FDA COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) Initiative Summary Report
• 01/2021: Advancing New Alternative Methodologies at FDA
  Report highlights activities FDA is undertaking to spur the development of new regulatory approaches that can help improve predictivity--and potentially replace, reduce and/or refine animal testing.
• 10/2020: Executive Order 13944 List of Essential Medicines, Medical Countermeasures, and Critical Inputs
• 09/2019: FDA’s Technology Modernization Action Plan
• 09/2019: Pediatric Labeling of Orphan Drugs, Report to Congress
• 07/2019: FDA Safe Importation Action Plan
• 08/2018: Quantities of opioid analgesics dispensed from retail pharmacies approach the lowest levels in 15 years 
  A recent FDA analysis of commercially available data showed steep drops in dispensing of opioid analgesics in retail outpatient settings. 
• 05/2018: Expanded Access Program Report 
  Report summarizes the results of an independent assessment. The findings reflect the perspectives of patients and their advocates/caregivers, physicians, health system representatives, payers, institutional review boards (IRBs), manufacturers, and FDA staff.
• 03/2018: FDA Analysis of Long-Term Trends in Prescription Opioid Analgesic Products: Quantity, Sales, and Price Trends 
  FDA White Paper
• 01/2018: Healthy Innovation, Safer Families: FDA's 2018 Policy Roadmap
  The FDA's four priority areas that will be the focus of additional policy activity in 2018
• 12/2017: FDA Information Technology Strategic Plan 
  FDA's information technology goals and priorities, 2015 - 2018
• 1/2017: 22 Case Studies Where Phase 2 and Phase 3 Trials Had Divergent Results 
  FDA studied 22 recent cases in which promising phase 2 clinical trial results were not confirmed in phase 3 clinical testing.
• 12/2016: Report to the Commissioner: FDA Review of the 2014 Discovery of Vials Labeled "Variola" and Other Vials Discovered in an FDA-Occupied Building on the NIH Campus
• 06/2016: Foods and Veterinary Medicine Strategic Plan 2012 - 2016
  Strategic plan for the Office of Foods and Veterinary Medicine 
• 12/2015: Women's Health Research Roadmap
  Strategic framework for research funded by the FDA Office of Women’s Health. 
• 09/2015: Report: Mission Possible: How FDA Can Move at the Speed of Science