Administrative Practices and Procedures; Good Guidance Practices
Information
Type
Rule
Regulated products
Published
September 19, 2000
Last updated
September 19, 2000
Description
Document number 00-23887. The Food and Drug Administration (FDA) is amending its administrative regulations to codify its policies and procedures for the development, issuance, and use of guidance documents. This action is necessary to comply with requirements of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The Modernization Act codified certain parts of the agency's current "Good Guidance Practices" (GGP's) and directed the agency to issue a regulation consistent with the act that specifies FDA's policies and procedures for the development, issuance, and use of guidance documents. The intended effect of this regulation is to make the agency's procedures for development, issuance, and use of guidance documents clear to the public.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)