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Center for Biologics Evaluation and Research: Difference between revisions
Center for Biologics Evaluation and Research (view source)
Revision as of 23:03, 9 January 2025
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{{Short description|FDA research center}} | {{Short description|FDA research center}} | ||
{{Redirect|CBER}} | {{Redirect|CBER}} | ||
{{Center for | {{Organization | ||
|OrganizationName=Center for Devices and Radiological Health | |||
|OrganizationType=Independent Agencies (Sub-organization) | |||
|Mission=The Center for Devices and Radiological Health (CDRH) protects and promotes public health by ensuring patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. CDRH facilitates medical device innovation by advancing regulatory science and providing transparent regulatory pathways. | |||
|OrganizationExecutive=Director | |||
|Employees=1800 | |||
|Budget= | |||
|Website=https://www.fda.gov/medical-devices | |||
|Services=Medical device approval; Radiation safety regulation; Premarket and postmarket device safety; Regulatory science research; Compliance and enforcement | |||
|ParentOrganization=U.S. Food and Drug Administration (FDA) | |||
|CreationLegislation= | |||
|Regulations=21 CFR Parts 800-1299 (Medical Devices) | |||
|HeadquartersLocation=39.035282, -77.028922 | |||
|HeadquartersAddress=10903 New Hampshire Ave, Silver Spring, MD 20993 | |||
}} | |||
The '''Center for Biologics Evaluation and Research''' ('''CBER''') is one of six main centers for the [[Food and Drug Administration|U.S. Food and Drug Administration]] (FDA), which is a part of the [[U.S. Department of Health and Human Services]]. The current Director of CBER is [[Peter Marks (physician)|Peter Marks]], M.D., PhD. CBER is responsible for assuring the safety, purity, potency, and effectiveness of [[biologic medical product|biologics]] and related products (such as [[vaccine]]s, live biotherapeutics ([[probiotic]]s), [[blood product]]s, and [[Cell therapy|cell, tissue]], and [[Gene therapy|gene]] therapies). Not all biologics are regulated by CBER. [[Monoclonal antibodies]] and other therapeutic proteins are regulated by the FDA [[Center for Drug Evaluation and Research]] (CDER). | The '''Center for Biologics Evaluation and Research''' ('''CBER''') is one of six main centers for the [[Food and Drug Administration|U.S. Food and Drug Administration]] (FDA), which is a part of the [[U.S. Department of Health and Human Services]]. The current Director of CBER is [[Peter Marks (physician)|Peter Marks]], M.D., PhD. CBER is responsible for assuring the safety, purity, potency, and effectiveness of [[biologic medical product|biologics]] and related products (such as [[vaccine]]s, live biotherapeutics ([[probiotic]]s), [[blood product]]s, and [[Cell therapy|cell, tissue]], and [[Gene therapy|gene]] therapies). Not all biologics are regulated by CBER. [[Monoclonal antibodies]] and other therapeutic proteins are regulated by the FDA [[Center for Drug Evaluation and Research]] (CDER). | ||