CargoAdmin, Bureaucrats, Moderators (CommentStreams), fileuploaders, Interface administrators, newuser, Push subscription managers, Suppressors, Administrators
5,233
edits
Office of Global Regulatory Operations and Policy: Difference between revisions
Office of Global Regulatory Operations and Policy (view source)
Revision as of 00:17, 15 February 2025
, 15 FebruaryText replacement - "|ParentOrganization=U.S. Food and Drug Administration, U.S. Department of Health and Human Services" to "|ParentOrganization=Food and Drug Administration |TopOrganization=Department of Health and Human Services"
m (Text replacement - "|ParentOrganization=U.S. Food and Drug Administration, U.S. Department of Health and Human Services" to "|ParentOrganization=Food and Drug Administration |TopOrganization=Department of Health and Human Services") |
|||
| (3 intermediate revisions by one other user not shown) | |||
| Line 3: | Line 3: | ||
|OrganizationType=Executive Departments (Sub-organization) | |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. | |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. | ||
|ParentOrganization= | |ParentOrganization=Food and Drug Administration | ||
|TopOrganization=Department of Health and Human Services | |||
|Employees=5000 | |Employees=5000 | ||
|Budget=Part of the FDA's budget; specific allocation not publicly detailed | |Budget=Part of the FDA's budget; specific allocation not publicly detailed | ||
| Line 34: | Line 35: | ||
=== Regions === | === Regions === | ||
It is organized into five regions | It is organized into five regions: | ||
* Northeast (NER) | * Northeast (NER) | ||
| Line 58: | Line 59: | ||
=== Field laboratories === | === Field laboratories === | ||
The Office of Regulatory Affairs operates thirteen field laboratories. The field science laboratories were historically part of the FDA districts infrastructure but are now independent entities. ORA has five regional, six district, and two specialty laboratories such as the Forensic Chemistry Center (FCC) and the Winchester Engineering and Analytical Center (WEAC).<ref>{{cite web |url=https://www.fda.gov/ScienceResearch/FieldScience/ |title= U.S. FDA Field Science and Laboratories |website= U.S. FDA Science & Research |publisher=U.S. Food & Drug Administration}}</ref> | The Office of Regulatory Affairs operates thirteen field laboratories. The field science laboratories were historically part of the FDA districts infrastructure but are now independent entities. ORA has five regional, six district, and two specialty laboratories such as the Forensic Chemistry Center (FCC) and the Winchester Engineering and Analytical Center (WEAC).<ref>{{cite web |url=https://www.fda.gov/ScienceResearch/FieldScience/ |title= U.S. FDA Field Science and Laboratories |website= U.S. FDA Science & Research |publisher=U.S. Food & Drug Administration}}</ref> | ||
Below is the list of the 13 field laboratories operated by the Office of Regulatory Affairs (ORA): | |||
Regional Laboratories: | |||
* [[Northeast Regional Laboratory]] (NERL) - Jamaica, NY | |||
* [[Central Regional Laboratory]] (CRL) - Jefferson, AR | |||
* [[Southeast Regional Laboratory]] (SERL) - Atlanta, GA | |||
* [[Southwest Regional Laboratory]] (SWRL) - Dallas, TX | |||
* [[Pacific Regional Laboratory Northwest]] (PRL-NW) - Bothell, WA | |||
District Laboratories: | |||
* [[Pacific Regional Laboratory Southwest]] (PRL-SW) - Irvine, CA | |||
* [[Mid-Atlantic Laboratory]] (MAL) - Winchester, VA | |||
* [[New England Laboratory]] (NEL) - Bedford, MA | |||
* [[Orlando Laboratory]] (ORDL) - Orlando, FL | |||
* [[San Francisco Laboratory]] (SFL) - Alameda, CA | |||
* [[Kansas City Laboratory]] (KCL) - Lenexa, KS | |||
Specialty Laboratories: | |||
* [[Forensic Chemistry Center]] (FCC) - Cincinnati, OH | |||
* [[Winchester Engineering and Analytical Center]] (WEAC) - Winchester, MA | |||
== Manuals == | == Manuals == | ||
ORA operations are generally conducted according to the: | ORA operations are generally conducted according to the: | ||
* | * Compliance Program Guidance Manual (CPGM),<ref>{{cite web |url=https://www.fda.gov/ICECI/ComplianceManuals/ComplianceProgramManual/ |title= U.S. FDA Compliance Program Guidance Manual |website= U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations |publisher=U.S. Food & Drug Administration}}</ref> | ||
* | * Investigations Operations Manual (IOM),<ref>{{cite web |url=https://www.fda.gov/ICECI/Inspections/IOM/ |title= U.S. FDA Investigations Operations Manual |website= U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations |publisher=U.S. Food & Drug Administration}}</ref> | ||
* | * Regulatory Procedures Manual (RPM).<ref>{{cite web |url=https://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ |title= U.S. FDA Regulatory Procedures Manual |website= U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations |publisher=U.S. Food & Drug Administration}}</ref> | ||
==Related== | ==Related== | ||