Zdrowie i gospodarka · 14.02.2000
Administrative Practices and Procedures; Good Guidance Practices
The Food and Drug Administration (FDA) is proposing to amend its administrative regulations to codify its policies and procedures for the development, issuance, and use of guidance documents. This action is necessary in order to comply with requirements of the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDAMA codifies certain parts of the agency's current "Good Guidance Practices" (GGP's) and directs the agency to issue a regulation that is consistent with the Federal Food, Drug, and Cosmetic Act (the act) and 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.