4: The Food and Drug Administration
- Page ID
- 39497
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Learning Objectives
- Explore the origin of regulations in the U.S.
- Discuss the role and organization of the Food and Drug Administration
- Identify products the FDA has regulatory authority
- Explore the various FDA offices & Centers responsible for product approval
- Distinguish between CFR, Guidelines, and Points to Ponder
- Demonstrate the use of the eCFR database to locate regulations
- 4.1: Consumer Safety and Health
- The FDA's authority to regulate products has changed over time significantly. Advancements in science have provided new tools to protect the public health. At times, public health crises have compelled urgent changes, and at other times, reform has taken place slowly through a length and controlled administrative process. Through it all, FDA's steadfast commitment to protecting the public health has remained at the core of all regulatory action.
- 4.2: The Food and Drug Administration (FDA)
- The FDA is an administrative agency created to regulate food and drug supplies in the United States for the safety and health of its citizens. FDA is an agency within the Department of Health and Human Services. While the FDA has traditionally focused on the US markets, with the global market growth (of imports and exports of products and raw materials) the FDA now manages over 2 trillion dollars of goods manufactured in over 150 nations worldwide (FDA, FDA Global engagement report, 2016).
- 4.3: The Code of Federal Regulations (CFR)
- The CFR is a massive set of regulations, published annually, where all the federal agencies post their rules. It provides information (based on quality techniques) on quality systems in the laboratory (QSR), manufacturing practices, laboratory practices, and clinical practices. Due to the sheer volume of information available through the CFR, it is useful to know how it is organized.