CargoAdmin, Bureaucrats, Moderators (CommentStreams), fileuploaders, Interface administrators, newuser, Push subscription managers, Suppressors, Administrators
5,230
edits
Center for Biologics Evaluation and Research: Difference between revisions
Center for Biologics Evaluation and Research (view source)
Revision as of 23:28, 20 February 2025
, 20 Februaryno edit summary
m (1 revision imported) |
No edit summary |
||
| (11 intermediate revisions by 2 users not shown) | |||
| Line 1: | Line 1: | ||
{{Organization | |||
|OrganizationName=Center for Biologics Evaluation and Research | |||
|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. | |||
|ParentOrganization=Food and Drug Administration | |||
|TopOrganization=Department of Health and Human Services | |||
|Employees=1800 | |||
|OrganizationExecutive=Director | |||
|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) | |||
|HeadquartersLocation=39.03528, -77.02892 | |||
|HeadquartersAddress=10903 New Hampshire Ave, Silver Spring, MD 20993 | |||
|Website=https://www.fda.gov/medical-devices | |||
}} | |||
{{Short description|FDA research center}} | {{Short description|FDA research center}} | ||
{{Redirect|CBER}} | {{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). | ||
| Line 33: | Line 47: | ||
==Flu vaccines== | ==Flu vaccines== | ||
CBER's Vaccines and Related Biological Products Advisory Committee meets annually for a discussion and vote concerning the next year's [[influenza vaccine]] virus selection.<ref>{{cite web |url=http://origin.www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4087T1.DOC |archive-url=https://web.archive.org/web/20090901160557/http://origin.www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4087T1.DOC |url-status=dead |archive-date=2009-09-01 |website=origin.www.fda.gov |title=Transcript of U.S. FDA Center for Biologics Evaluation and Research Vaccines and Related Biological Products Advisory Committee's 101st meeting of February 16, 2005 |format=DOC }}</ref><ref>{{Cite web|url=http://origin.www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4087T1.DOC|archive-url=https://web.archive.org/web/20090901160557/http://origin.www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4087T1.DOC|url-status=dead|archive-date=September 1, 2009|title=in Google provided HTML format}}</ref> | CBER's [[Vaccines and Related Biological Products Advisory Committee]] meets annually for a discussion and vote concerning the next year's [[influenza vaccine]] virus selection.<ref>{{cite web |url=http://origin.www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4087T1.DOC |archive-url=https://web.archive.org/web/20090901160557/http://origin.www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4087T1.DOC |url-status=dead |archive-date=2009-09-01 |website=origin.www.fda.gov |title=Transcript of U.S. FDA Center for Biologics Evaluation and Research Vaccines and Related Biological Products Advisory Committee's 101st meeting of February 16, 2005 |format=DOC }}</ref><ref>{{Cite web|url=http://origin.www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4087T1.DOC|archive-url=https://web.archive.org/web/20090901160557/http://origin.www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4087T1.DOC|url-status=dead|archive-date=September 1, 2009|title=in Google provided HTML format}}</ref> | ||
==Review and approval times== | ==Review and approval times== | ||
| Line 58: | Line 72: | ||
===Current committees=== | ===Current committees=== | ||
* Allergenic Products Advisory Committee (APAC) | * [[Allergenic Products Advisory Committee]] (APAC) | ||
* Anesthetic and Analgesic Drug Products Advisory Committee | * [[Anesthetic and Analgesic Drug Products Advisory Committee]] | ||
* Antimicrobial Drugs Advisory Committee (AMDAC) – formerly called the Anti-Infective Drugs Advisory Committee | * [[Antimicrobial Drugs Advisory Committee]] (AMDAC) – formerly called the Anti-Infective Drugs Advisory Committee | ||
* Arthritis Advisory Committee | * [[Arthritis Advisory Committee]] | ||
* Blood Products Advisory Committee (BPAC) | * [[Blood Products Advisory Committee]] (BPAC) | ||
* Bone, Reproductive and Urologic Drugs Advisory Committee – formerly called the Reproductive Health Drugs Advisory Committee | * [[Bone, Reproductive and Urologic Drugs Advisory Committee]] – formerly called the Reproductive Health Drugs Advisory Committee | ||
* 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]] | * [[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) | ||
* Tobacco Products Scientific Advisory Committee (TPSAC) | * [[Tobacco Products Scientific Advisory Committee]] (TPSAC) | ||
* Vaccines and Related Biological Products Advisory Committee (VRBPAC) | * [[Vaccines and Related Biological Products Advisory Committee]] (VRBPAC) | ||
===Former committees=== | ===Former committees=== | ||