About FDA
What is the difference between the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA regulations, and FDA guidance?
The Federal Food, Drug, and Cosmetic Act (FD&C Act) is a federal law enacted by Congress. It and other federal laws establish the legal framework within which FDA operates. The FD&C Act can be found in the United States Code, which contains all general and permanent U.S. laws, beginning at 21 U.S.C. 301.
FDA develops regulations based on the laws set forth in the FD&C Act or other laws under which FDA operates. FDA follows the procedures required by the Administrative Procedure Act, another federal law, to issue FDA regulations. This typically involves a process known as "notice and comment rulemaking" that allows for public input on a proposed regulation before FDA issues a final regulation. FDA regulations are also federal laws, but they are not part of the FD&C Act. FDA regulations can be found in Title 21 of the Code of Federal Regulations (CFR).
FDA follows the procedures required by its "Good Guidance Practice" regulation to issue FDA guidance. FDA guidance describes the agency’s current thinking on a regulatory issue. Guidance is not legally binding on the public or FDA. The Good Guidance Practice regulation can be found at 21 CFR 10.115.
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- FDA Basics Metrics: July 2012
- FDA Basics Metrics: June 2012
- FDA Basics Metrics: December 2011
- FDA Basics Metrics: May 2012
- FDA Basics Metrics: April 2012
- FDA Basics Metrics: January 2012
- FDA Basics Metrics: March 2012
- FDA Basics Metrics: February 2012
- Who should I contact about products not regulated by FDA?
- What doesn’t FDA regulate? How do I contact the agencies that do?
- What does FDA regulate?
- How can I be notified about new import alerts?
- How is FDA organized?
- How can the public request documents from FDA?
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- FDA MedWatch Webinar
- FDA Basics Metrics: November 2011
- FDA Basics Metrics: October 2011
- FDA Basics Metrics : September 2011
- FDA Basics Metrics: August 2011
- FDA Basics Metrics: July 2011
- FDA Basics Metrics: June 2011
- FDA Basics Metrics: May 2011
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