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Office of Global Regulatory Operations and Policy: Difference between revisions
Office of Global Regulatory Operations and Policy (view source)
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{{ | {{Organization | ||
|OrganizationName= Office of Global Regulatory Operations and Policy | |||
|OrganizationType= Executive Departments (Sub-organization) | |||
|Mission= To enforce federal laws governing biologics, cosmetics, dietary supplements, drugs, food, medical devices, radiation-emitting electronic devices, tobacco products, and veterinary medicine products, ensuring they are safe, effective, and accurately represented to the public. It oversees global regulatory compliance to protect public health both domestically and internationally. | |||
|OrganizationExecutive= Deputy Commissioner | |||
|Employees= 5000 (estimate, including field operations) | |||
|Budget= Part of the FDA's budget; specific allocation not publicly detailed | |||
|Website=https://www.fda.gov/about-fda/office-global-regulatory-operations-and-policy | |||
|Services= Inspections; compliance; enforcement; laboratory analysis; global regulatory policy; international collaboration | |||
|ParentOrganization= U.S. Food and Drug Administration, U.S. Department of Health and Human Services | |||
|CreationLegislation= | |||
|Regulations= Oversees enforcement under various acts such as the Federal Food, Drug, and Cosmetic Act | |||
|HeadquartersLocation= 38.893624, -77.025481 | |||
|HeadquartersAddress= 10903 New Hampshire Avenue, Silver Spring, MD 20993 | |||
}} | |||
[[File:FDA Bldg 32 - Pathway to Main Entrance (5161375442).jpg|thumb|FDA Building 32 houses the Office of the Commissioner and the Office of Regulatory Affairs.]] | [[File:FDA Bldg 32 - Pathway to Main Entrance (5161375442).jpg|thumb|FDA Building 32 houses the Office of the Commissioner and the Office of Regulatory Affairs.]] | ||
The '''Office of Global Regulatory Operations and Policy''' ('''GO'''),<ref>{{cite web |url=https://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ |title=Office of Global Regulatory Operations and Policy |website=U.S. FDA Organization |publisher=U.S. Food & Drug Administration}}</ref> also known as the '''Office of Regulatory Affairs''' ('''ORA'''),<ref>{{cite web |url=https://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ |title=Office of Regulatory Affairs |website=U.S. FDA Organization |date=22 September 2021 |publisher=U.S. Food & Drug Administration}}</ref> is the part of the [[Food and Drug Administration (United States)|U.S. Food and Drug Administration]] (FDA) enforcing the federal laws governing biologics, cosmetics, dietary supplements, drugs, food, medical devices, radiation-emitting electronic devices, tobacco products, and veterinary medicine products which may have potentially harmful side effects for the consumer.<ref>{{cite web |url=https://www.fda.gov/RegulatoryInformation/ |title= U.S. FDA Regulatory Information |date= 23 April 2019 |publisher=U.S. Food & Drug Administration}}</ref> | The '''Office of Global Regulatory Operations and Policy''' ('''GO'''),<ref>{{cite web |url=https://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ |title=Office of Global Regulatory Operations and Policy |website=U.S. FDA Organization |publisher=U.S. Food & Drug Administration}}</ref> also known as the '''Office of Regulatory Affairs''' ('''ORA'''),<ref>{{cite web |url=https://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ |title=Office of Regulatory Affairs |website=U.S. FDA Organization |date=22 September 2021 |publisher=U.S. Food & Drug Administration}}</ref> is the part of the [[Food and Drug Administration (United States)|U.S. Food and Drug Administration]] (FDA) enforcing the federal laws governing biologics, cosmetics, dietary supplements, drugs, food, medical devices, radiation-emitting electronic devices, tobacco products, and veterinary medicine products which may have potentially harmful side effects for the consumer.<ref>{{cite web |url=https://www.fda.gov/RegulatoryInformation/ |title= U.S. FDA Regulatory Information |date= 23 April 2019 |publisher=U.S. Food & Drug Administration}}</ref> | ||