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.
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
Women's Health Research Roadmap
Strategic framework for research funded by the FDA Office of Women’s Health.
The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies The real and potential harms to patients and to public health from certain laboratory developed tests (LDTs).
FDA Information Technology Strategic Plan
FDA's information technology goals and priorities, 2015 - 2018
Recommendations of the Advisory Committee to the Director, CDC, Concerning Laboratory Safety at the Food and Drug Administration
Report of the External Laboratory Safety Workgroup
Mission Possible: How FDA Can Move at the Speed of Science (PDF - 621KB)
Report of the Science Looking Forward Subcommittee to the FDA Science Board
FDA's Role in Ensuring American Patients Have Access to Safe and Effective Medical Device Technology
Discusses FDA initiatives to promote access to safe and effective medical devices and shows how FDA’s device program has adapted to changes in the marketplace, scientific advances, and new technology.
Targeted Drug Development: Why Are Many Diseases Lagging Behind?
White paper describing the state of scientific knowledge and its effect on drug development in four key disease areas.
White Paper: FDA and Accelerating the Development of the New Pharmaceutical Therapies
Current information on FDA's drug approval process
FDA Strategic Priorities: 2014 - 2018
Articulates the FDA's goals and priorities and creates a framework that will allow us to integrate and achieve our five strategic priorities: regulatory science, globalization, safety and quality, smart regulation, and stewardship.
Paving the Way for Personalized Medicine(PDF - 854KB)
FY 2012 Innovative Drug Approvals
Bringing Life-saving Drugs to Patients Quickly and Efficiently
Improvements in Device Review
Results of CDRH's Plan of Action for Premarket Review of Devices
Strategic Plan for Risk Communication
FDA's strategy for improving communication about regulated products
Foods and Veterinary Medicine (FVM) Program’s Strategic Plan Fiscal Years 2016–2025
Through effective global engagement, FDA is working with its many international partners to weave a global safety net that benefi ts public health in the United States and around the world.
Driving Biomedical Innovation: Initiatives for Improving Products for Patients
Redoubling the agency’s efforts to encourage innovations that will promote public health as well as strengthen the American economy
Communicating Risks and Benefits: An Evidence-Based User's Guide
Scientific foundations for effective communication of risks and benefits
Strategic Plan for Regulatory Science
FDA's plan to protect consumers by applying the best possible science to its regulatory activities
Pathway to Global Product Safety and Quality
Strategy to ensure the safety and quality of FDA-regulated products imported into the U.S.
Advancing Regulatory Science for Public Health
Outlines a broad vision for advancing regulatory science and unleashing its potential to improve public health