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.
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
FDA Information Management Strategic Plan
FDA's information management goals and priorities, FY 2012 - FY 2016
Foods and Veterinary Medicine Strategic Plan 2012 - 2016
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