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Guideline

The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.

ORA Quality Manual
Internet:http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/UCM136320.pdf
Origin/Publisher: 
Content:The ORA Quality Manual contains the required policy elements to structure the Office of Regulatory Affairs (ORA) quality management system (QMS) for internal work activities.
Document Type:Quality Manual