Center for Biologics Evaluation and Research

The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the

• hyperimmune products, and antitoxins
  .
  • Blood and blood products activities are managed through the Office of Blood Research and Review (OBRR)[2]
• Human cells, tissues, and cellular and tissue-based products (HCT/Ps), except vascularized organs for transplantation and the associated blood vessels.
• Vaccines for use in humans.
• Diagnostic and therapeutic allergenic extracts.
• Live biotherapeutics (probiotics).
• Some medical devices, specifically test kits for HIV, tests used to screen blood donations, blood bank collection machines and equipment, and blood bank computer software.
• Xenotransplantation
• Historically, CBER was responsible for some therapeutic proteins, such as monoclonal antibodies. Control of these has been transferred to CDER. Some other drugs, such as certain anticoagulants and plasma volume expanders remain under the control of CBER.

Authority

As of July 2006 CBER's authority resides in sections 351 and 361 of the

Section 351 of the Public Health Service Act requires licensure of biological products that travel in interstate commerce in the United States. CBER may deny licensure or suspend or cancel a current license if a manufacturer does not comply with requirements. Unlicensed blood products used within the boundaries of a state are not unusual, and these products are subject to general regulations from other FDA legal authorities.^{[citation needed]}

Section 361 of the same act allows the Surgeon General to make and enforce regulations to control the interstate spread of communicable disease. This broad authority has been delegated to the FDA through a Memorandum of Understanding. Many of the products overseen by CBER are also considered drugs, and are subject to the same rules and regulations as any other drug product from the Food, Drug, and Cosmetic Act.^{[citation needed]}

From these legal authorities, CBER publishes regulations which are included in the first chapter Title 21 of the Code of Federal Regulations. Most of the regulations specific to CBER are found from 21CFR600-680. 21CFR1271 contains the rules for HCT/Ps. For products which are also drugs, such as blood for transfusion, rules in 21CFR200 and following apply. Other general rules, such as the regulations for clinical trials involving human subjects in 21CFR50, may also apply.^{[citation needed]}

In addition to these laws and guidelines, CBER also publishes guidance documents. These are not requirements, but are generally followed by industry. Licensed manufacturers are expected to adopt either the guidance or an equivalent process. In some cases, the guidance documents have the force of regulation because they are written to clarify existing rules.^{[citation needed]}

Vaccine Adverse Event Reporting System

As of 2003, the Vaccine Adverse Event Reporting System was based on a data integration platform from Informatica. The FDA uses this software to analyze data on adverse reactions to vaccines and other biological, in order to improve regulation.^[4]

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.^[5][6]

Review and approval times

According to numbers from the FDA, in 2001 the CBER reviewed 16 Biologics License Applications (BLAs) with a median review time of 13.8 months and a median approval time of 20.3 months.^[7]

History

CBER's history began with

In 1997, Congress re-authorized user fees, and research previously done at taxpayer expense began to be charged to manufacturers.[8] CBER's research work has diminished dramatically since then.^[8]

In 2002, the FDA transferred a number of biologically produced therapeutics to CDER.^[8] CBER regulates a number of biologics-related products, including blood tests, computer software, and devices related to blood transfusion, which industry representatives would like to see handled by the much brisker Center for Devices and Radiological Health.^[8]

Advisory committees

Federal law and DHS policy define the procedures for the CBER to establish advisory committees,^[9] which may further be divided into panels and must be renewed every two years.^[10] As of 2018^[update] the FDA has 31 advisory committees.

During the COVID-19 pandemic in 2020, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) received media attention as it reviewed COVID-19 vaccines before their approval.^{[citation needed]}

Current committees

• Allergenic Products Advisory Committee (APAC)
• Anesthetic and Analgesic Drug Products Advisory Committee
• Antimicrobial Drugs Advisory Committee (AMDAC) – formerly called the Anti-Infective Drugs Advisory Committee
• Arthritis Advisory Committee
• Blood Products Advisory Committee (BPAC)
• Bone, Reproductive and Urologic Drugs Advisory Committee – formerly called the Reproductive Health Drugs Advisory Committee
• Cardiovascular and Renal Drugs Advisory Committee
• Cellular, Tissue, and Gene Therapies Advisory Committee
• Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC)
• Device Good Manufacturing Practice Advisory Committee (DGMPAC)
• Drug Safety and Risk Management Advisory Committee
• Endocrinologic and Metabolic Drugs Advisory Committee
• Gastrointestinal Drugs Advisory Committee
• Medical Devices Advisory Committee (MDAC) – 18 panels
• Medical Imaging Drugs Advisory Committee
• National Mammography Quality Assurance Advisory Committee (NMQAAC)
• Nonprescription Drugs Advisory Committee
• Oncologic Drugs Advisory Committee
• Patient Engagement Advisory Committee
• Pediatric Advisory Committee
• Peripheral and Central Nervous System Drugs Advisory Committee
• Pharmaceutical Science and Clinical Pharmacology Advisory Committee
• Pharmacy Compounding Advisory Committee
• Psychopharmacologic Drugs Advisory Committee
• Pulmonary-Allergy Drugs Advisory Committee
• Risk Communication Advisory Committee
• Science Advisory Board (SAB) to the National Center for Toxicological Research
• Science Board to the Food and Drug Administration
• Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC)
• Tobacco Products Scientific Advisory Committee (TPSAC)
• Vaccines and Related Biological Products Advisory Committee (VRBPAC)

Former committees

• Antiviral Drugs Advisory Committee – terminated February 15, 2015
• Food Advisory Committee – terminated December 12, 2017
• Transmissible Spongiform Encephalopathies Advisory Committee – terminated June 9, 2016
• Veterinary Medicine Advisory Committee – terminated September 24, 2013

See also

• Risk Evaluation and Mitigation Strategies

References

External links

Scholia has a profile for Center for Biologics Evaluation and Research (Q5059524).

• Official website
• 100 Years of Biologics Regulation Centennial anniversary reports