FDA Compliance Policy Guides Manual, March 1995

摘要

This is the first edition of the Compliance Policy Guide Manual in a bound form.With this edition, a number of changes in its content, organization and distribution have been made. The reasons for the changes are to make the Compliance Policy Guide Manual user friendly, easier to maintain and economical to substantially increase distribution within FDA. As to content, the most significant change is that the various cooperative agreements, MOU's etc., are not part of this bound edition. For the time being, the cooperative agreements located in chapters 55 and up will be located in a loose leaf format and collectively will be known as the Cooperative Agreement Manual. The Manual has been organized into six chapters, five program areas and one general for each of the FDA Centers. The Compliance Policy Guide numbers have not been changed although a location section number has been added. It is hoped that the reorganization will result in grouping similar policies together for easier use and reference. In addition, a rather extensive key word index has been added which will enable one to locate any and all related policies to any subject.