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Center for Drug Evaluation and Research: Difference between revisions
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{{Organization | |||
{{Organization | |||
|OrganizationName=Center for Drug Evaluation and Research | |OrganizationName=Center for Drug Evaluation and Research | ||
|OrganizationType=Independent Agencies (Sub-organization) | |OrganizationType=Independent Agencies (Sub-organization) | ||
|Mission=The Center for Drug Evaluation and Research (CDER) ensures that safe and effective drugs are available to improve the health of people in the United States. CDER evaluates new drugs before they can be sold, monitors drug safety, and provides accurate, science-based drug information to the public. | |Mission=The Center for Drug Evaluation and Research (CDER) ensures that safe and effective drugs are available to improve the health of people in the United States. CDER evaluates new drugs before they can be sold, monitors drug safety, and provides accurate, science-based drug information to the public. | ||
|ParentOrganization=Food and Drug Administration | |||
|TopOrganization=Department of Health and Human Services | |||
|Employees=4500 | |||
|OrganizationExecutive=Director | |OrganizationExecutive=Director | ||
|Services=Drug approval; Drug safety monitoring; Drug development guidance; Educational outreach; Post-market surveillance | |Services=Drug approval; Drug safety monitoring; Drug development guidance; Educational outreach; Post-market surveillance | ||
|Regulations=21 CFR Parts 300-499 (Drugs for Human Use) | |Regulations=21 CFR Parts 300-499 (Drugs for Human Use) | ||
|HeadquartersLocation=39. | |HeadquartersLocation=39.02886, -76.98316 | ||
|HeadquartersAddress=10903 New Hampshire Ave, Silver Spring, MD 20993 | |HeadquartersAddress=10903 New Hampshire Ave, Silver Spring, MD 20993 | ||
|Website=https://www.fda.gov/drugs | |||
}} | }} | ||
{{Short description|US Food and Drug Administration division}} | |||
{{Regulation of therapeutic goods in the United States}} | {{Regulation of therapeutic goods in the United States}} | ||
[[File:FDA Bldg 51 - Main Entrance (5161374834).jpg|thumb|FDA Building 51 is one of the main buildings in its White Oak campus that houses the Center for Drug Evaluation and Research.]] | [[File:FDA Bldg 51 - Main Entrance (5161374834).jpg|thumb|FDA Building 51 is one of the main buildings in its White Oak campus that houses the Center for Drug Evaluation and Research.]] | ||
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=== Office of New Drugs === | === Office of New Drugs === | ||
{{Main|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 | |||
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 === | === Office of Generic Drugs === | ||
{{Main|Office of Generic Drugs}} | |||
This office reviews generic drug applications to ensure generic drugs are equivalent to their branded forms | |||
=== Office of Strategic Programs === | === Office of Strategic Programs === | ||
{{Main|Office of Strategic Programs}} | |||
This office is responsible for business programs, represents CDER in the FDA Bioinformatics Board, and communicates with other agencies | |||
=== Office of Pharmaceutical Quality === | === Office of Pharmaceutical Quality === | ||
{{Main|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. | |||
=== Office of Surveillance and Epidemiology === | === Office of Surveillance and Epidemiology === | ||
{{Main|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 | |||
=== Office of Translational Sciences === | === Office of Translational Sciences === | ||
{{Main|Office of Translational Sciences}} | |||
This office promotes collaboration across offices in CDER by maintaining databases and biostatistical tools for evaluating drugs | |||
=== Office of Medical and Regulatory Policy === | === Office of Medical and Regulatory Policy === | ||
{{Main|Office of Medical and Regulatory Policy}} | |||
This office develops and reviews guidelines pertinent to CDER's mission of ensuring the safety of drugs | |||
=== Office of Compliance === | === Office of Compliance === | ||
{{Main|Office of Compliance}} | |||
This office ensures compliance with regulations relating to drug development and marketing | |||
==History== | ==History== | ||