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Center for Biologics Evaluation and Research: Difference between revisions
Center for Biologics Evaluation and Research (view source)
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{{Organization | |||
|OrganizationName=Center for Biologics Evaluation and Research | |||
{{Organization | |||
|OrganizationName=Center for | |||
|OrganizationType=Independent Agencies (Sub-organization) | |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. | |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. | ||
|ParentOrganization=Food and Drug Administration | |||
|TopOrganization=Department of Health and Human Services | |||
|Employees=1800 | |||
|OrganizationExecutive=Director | |OrganizationExecutive=Director | ||
|Services=Medical device approval; Radiation safety regulation; Premarket and postmarket device safety; Regulatory science research; Compliance and enforcement | |Services=Medical device approval; Radiation safety regulation; Premarket and postmarket device safety; Regulatory science research; Compliance and enforcement | ||
|Regulations=21 CFR Parts 800-1299 (Medical Devices) | |Regulations=21 CFR Parts 800-1299 (Medical Devices) | ||
|HeadquartersLocation=39. | |HeadquartersLocation=39.03528, -77.02892 | ||
|HeadquartersAddress=10903 New Hampshire Ave, Silver Spring, MD 20993 | |HeadquartersAddress=10903 New Hampshire Ave, Silver Spring, MD 20993 | ||
|Website=https://www.fda.gov/medical-devices | |||
}} | }} | ||
{{Short description|FDA research center}} | |||
{{Redirect|CBER}} | |||
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). | ||
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* [[Cardiovascular and Renal Drugs Advisory Committee]] | * [[Cardiovascular and Renal Drugs Advisory Committee]] | ||
* [[Cellular, Tissue, and Gene Therapies Advisory Committee]] | * [[Cellular, Tissue, and Gene Therapies Advisory Committee]] | ||
* | * [[Dermatologic and Ophthalmic Drugs Advisory Committee]] (DODAC) | ||
* [[Device Good Manufacturing Practice Advisory Committee]] (DGMPAC) | * [[Device Good Manufacturing Practice Advisory Committee]] (DGMPAC) | ||
* [[Drug Safety and Risk Management Advisory Committee] | * [[Drug Safety and Risk Management Advisory Committee]] | ||
* [[Endocrinologic and Metabolic Drugs Advisory Committee]] | * [[Endocrinologic and Metabolic Drugs Advisory Committee]] | ||
* [[Gastrointestinal Drugs Advisory Committee] | * [[Gastrointestinal Drugs Advisory Committee]] | ||
* [[Medical Devices Advisory Committee]] (MDAC) – 18 panels | * [[Medical Devices Advisory Committee]] (MDAC) – 18 panels | ||
* [[Medical Imaging Drugs Advisory Committee]] | * [[Medical Imaging Drugs Advisory Committee]] | ||
* [[National Mammography Quality Assurance Advisory Committee]] (NMQAAC) | * [[National Mammography Quality Assurance Advisory Committee]] (NMQAAC) | ||
* [[Nonprescription Drugs Advisory Committee]] | * [[Nonprescription Drugs Advisory Committee]] | ||
* [[Oncologic Drugs Advisory Committee] | * [[Oncologic Drugs Advisory Committee]] | ||
* [[Patient Engagement Advisory Committee]] | * [[Patient Engagement Advisory Committee]] | ||
* [[Pediatric Advisory Committee]] | * [[Pediatric Advisory Committee]] | ||
* [[Peripheral and Central Nervous System Drugs Advisory Committee]] | * [[Peripheral and Central Nervous System Drugs Advisory Committee]] | ||
* [[Pharmaceutical Science and Clinical Pharmacology Advisory Committee] | * [[Pharmaceutical Science and Clinical Pharmacology Advisory Committee]] | ||
* [[Pharmacy Compounding Advisory Committee]] | * [[Pharmacy Compounding Advisory Committee]] | ||
* [[Psychopharmacologic Drugs Advisory Committee]] | * [[Psychopharmacologic Drugs Advisory Committee]] | ||
* [[Pulmonary-Allergy Drugs Advisory Committee]] | * [[Pulmonary-Allergy Drugs Advisory Committee]] | ||
* [[Risk Communication Advisory Committee]] | * [[Risk Communication Advisory Committee]] | ||
* [[Science Advisory Board]] (SAB) to the National Center for Toxicological Research]] | * [[Science Advisory Board]] (SAB) to the [[National Center for Toxicological Research]] | ||
* [[Science Board to the Food and Drug Administration]] | * [[Science Board to the Food and Drug Administration]] | ||
* [[Technical Electronic Product Radiation Safety Standards Committee]] (TEPRSSC) | * [[Technical Electronic Product Radiation Safety Standards Committee]] (TEPRSSC) | ||