CargoAdmin, Bureaucrats, Moderators (CommentStreams), fileuploaders, Interface administrators, newuser, Push subscription managers, Suppressors, Administrators
14,662
edits
Center for Drug Evaluation and Research: Difference between revisions
Center for Drug Evaluation and Research (view source)
Revision as of 22:56, 9 January 2025
, 9 January→Divisions
No edit summary |
|||
| Line 36: | Line 36: | ||
== Divisions == | == Divisions == | ||
CDER is divided into 8 sections with different responsibilities:<ref>{{Cite web |url=https://www.fda.gov/downloads/AboutFDA/CentersOffices/OrganizationCharts/UCM439876.pdf |title=Archived copy |website=[[Food and Drug Administration]] |access-date=2017-02-01 |archive-url=https://web.archive.org/web/20170113043256/https://www.fda.gov/downloads/AboutFDA/CentersOffices/OrganizationCharts/UCM439876.pdf |archive-date=2017-01-13 |url-status=dead }}</ref><ref>{{cite web|url=https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm075128.htm|title=About the Center for Drug Evaluation and Research - CDER Offices and Divisions|first=Center for Drug Evaluation and|last=Research|website=www.fda.gov|date=3 March 2022}}</ref> | CDER is divided into 8 sections with different responsibilities:<ref>{{Cite web |url=https://www.fda.gov/downloads/AboutFDA/CentersOffices/OrganizationCharts/UCM439876.pdf |title=Archived copy |website=[[Food and Drug Administration]] |access-date=2017-02-01 |archive-url=https://web.archive.org/web/20170113043256/https://www.fda.gov/downloads/AboutFDA/CentersOffices/OrganizationCharts/UCM439876.pdf |archive-date=2017-01-13 |url-status=dead }}</ref><ref>{{cite web|url=https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm075128.htm|title=About the Center for Drug Evaluation and Research - CDER Offices and Divisions|first=Center for Drug Evaluation and|last=Research|website=www.fda.gov|date=3 March 2022}}</ref> | ||
=== Office of New Drugs === | |||
:: This office is responsible for oversight of clinical trials and other studies during drug development, and for the evaluation of new drug applications | :: This office is responsible for oversight of clinical trials and other studies during drug development, and for the evaluation of new drug applications | ||
:: The Office of New Drugs is divided into several departments based on the indication of the drug (the medical need for which it is being proposed) | :: The Office of New Drugs is divided into several departments based on the indication of the drug (the medical need for which it is being proposed) | ||
=== Office of Generic Drugs === | |||
:: This office reviews generic drug applications to ensure generic drugs are equivalent to their branded forms | :: This office reviews generic drug applications to ensure generic drugs are equivalent to their branded forms | ||
=== Office of Strategic Programs === | |||
:: This office is responsible for business programs, represents CDER in the FDA Bioinformatics Board, and communicates with other agencies | :: This office is responsible for business programs, represents CDER in the FDA Bioinformatics Board, and communicates with other agencies | ||
=== Office of Pharmaceutical Quality === | |||
:: This office is responsible for integrating assessment, inspection, surveillance, policy, and research activities to strengthen pharmaceutical quality on a global scale. | :: This office is responsible for integrating assessment, inspection, surveillance, policy, and research activities to strengthen pharmaceutical quality on a global scale. | ||
=== Office of Surveillance and Epidemiology === | |||
:: This office is responsible for post-marketing surveillance to identify adverse effects that may not have been apparent during clinical trials, using the [[MedWatch]] program | :: This office is responsible for post-marketing surveillance to identify adverse effects that may not have been apparent during clinical trials, using the [[MedWatch]] program | ||
=== Office of Translational Sciences === | |||
:: This office promotes collaboration across offices in CDER by maintaining databases and biostatistical tools for evaluating drugs | :: This office promotes collaboration across offices in CDER by maintaining databases and biostatistical tools for evaluating drugs | ||
=== Office of Medical and Regulatory Policy === | |||
:: This office develops and reviews guidelines pertinent to CDER's mission of ensuring the safety of drugs | :: This office develops and reviews guidelines pertinent to CDER's mission of ensuring the safety of drugs | ||
=== Office of Compliance === | |||
:: This office ensures compliance with regulations relating to drug development and marketing | :: This office ensures compliance with regulations relating to drug development and marketing | ||