FDA Fundamentals
The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.
FDA is responsible for
- protecting the public health by assuring the safety, effectiveness, quality, and security of human and veterinary drugs, vaccines and other biological products, and medical devices. The FDA is also responsible for the safety and security of most of our nation’s food supply, all cosmetics, dietary supplements and products that give off radiation.
- regulating tobacco products. More...
FDA Overview
- What does FDA do?
- What does FDA regulate?
- How is FDA organized?
- How many people are employed by FDA and in what areas do they work?
- What is the difference between the Federal Food, Drug, and Cosmetic Act (FDCA), FDA regulations, and FDA guidance?
- What is FDA Basics for Industry?
- FDA at a Glance: Overview of FDA responsibilities and resources
Data, Methods and Limitations
- How does the Office of Cosmetics and Colors protect consumers from unsafe cosmetics?
- How does the Center for Drug Evaluation and Research ensure that drugs are safe and effective?
FDA History
Approval Process
- Can I tell if FDA has approved a product by looking at the label?
- Do patients and caregivers have a role in the approval process?
- How can I find information about clinical trials for a certain medical condition?
- Why are animals used for testing medical products?
Advisory Committees
- What is an FDA Advisory Committee?
- How does an individual become a member of an FDA advisory committee?
- What are the qualifications of a scientific member of an advisory committee?
- What is a conflict of interest?
- What is a financial conflict of interest waiver?
- How is a potential advisory committee member screened for conflicts of interests?
Safety
- How do I report a problem with an FDA-regulated product?
- What safety information is available for FDA-regulated medical products and foods?
- Can I buy medical products online? How do I know theyâre safe?
- What does FDA inspect?
- What is a recall?
Information about FDA
- How can the public request documents from FDA?
- How can I find out the status of my FOIA request?
- How do I find the latest information on the Web site? How do I sign up for e-mails and alerts?
- How can I share my ideas and suggestions with FDA?
- What is a docket? How do I submit comments to a docket? How do I find comments submitted to a docket?
- Where should I go to find consumer information on www.FDA.gov?
- What other government- supported websites does FDA recommend as reliable sources for health -related information?
- What non-government websites does FDA recommend?