Science & Research
Resources for You
Office of Scientific Integrity The FDA Ombudsman Office of Scientific Professional Development
- Staff Manual Guide - Scientific Integrity at FDA
Strategic Plan for Risk Communication (PDF)(PDF - 260KB)
- Guidance for Industry: Preparation and Public Availability of Information Given to Advisory Committee Members (PDF - 169KB)
- Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees (PDF - 106KB)
Scientific Integrity at FDA
FDA has launched this web page as a single source to find and reference all FDA principles, policies, and procedures related to scientific integrity. A recent Agency-wide policy presents FDA's key principles of scientific integrity and highlights important procedures and policies FDA is implementing to further those principles.
Science—both its quality and integrity—is the touchstone of everything we do at FDA. In carrying out our mission to protect and promote the public health, FDA needs the best scientific and technological information available to make decisions on the products we regulate. Critical to our ability to reach sound decisions and to retain the public's trust are high-quality data and a scientific review process that is thorough and unbiased.
Our scientific experts may hold differing views on what they conclude from data. There may be multiple options that can be considered during policy development or regulatory decision-making. However, in reaching our conclusions through a deliberative scientific process, FDA strives to present an evaluation and analysis of the data--including uncertainties--in an unbiased manner.
FDA has a long and continuing history of promoting an environment of robust scientific debate, where the integrity of information is ensured, all views are carefully considered, and scientific decisions are protected from political influence. In 2009, we established FDA's Office of Scientific Integrity (OSI). OSI works to:
1. ensure that FDA's policies and procedures are current and applied across the Agency;
2. resolve scientific disputes that may arise internally or externally and that are not resolved
at the Agency's Center levels; and
3. advise the Chief Scientist and other senior FDA leaders on appropriate responses.