Laboratory Information:
Center for Biologics Evaluation and Research
1401 Rockville Pike, Suite 200N
Rockville, MD 20852-1448
Website: http://www.fda.gov/BiologicsBloodVaccines
Technology Transfer Website: http://www.fda.gov/AboutFDA/business/ucm119486.htm
Agency/Department: Dept. of Health and Human Services
Region: Mid-Atlantic
FLC Laboratory Representative:
Mr. Dano Murphy
Phone: 301-827-0801
Fax: 301-827-0440
Email: murphyd@cber.fda.gov
Background/History of the Laboratory:
The Center for Biologics Evaluation and
Research (CBER) regulates biological products. Current authority for
this responsibility resides in Section 351 of the Public Health Service Act and in specific sections
of the Food
Drug and Cosmetic Act. CBER is committed to advancing the public health through innovative regulations
that
ensure the safety, effectiveness and timely delivery to patients of biological products. The mission
of CBER is to
protect and enhance the public health through the regulation of biological and related products including
blood,
vaccines, tissue, allergenics and biological therapeutics. CBER is responsible for ensuring the safety
of this
nation's entire blood supply and the products derived from it; the production and approval of safe and
effective
childhood vaccines, including any future AIDS vaccines; the proper oversight of human tissue for
transplantation; an adequate and safe supply of allergenic materials and anti-toxins; the safety and
efficacy of
biological therapeutics, including an exciting new array of biotechnology-derived products used to treat
diseases such as cancer and AIDS. Biologics, in contrast to drugs that are chemically synthesized, are
derived
from living sources (such as humans, animals, and microorganisms). Most biologics are complex mixtures
that are not easily identified or characterized, and many biologics are manufactured using biotechnology.
Biological products often represent the cutting-edge of biomedical research and, in time, may offer
the most
effective means to treat a variety of medical illnesses and conditions that presently have no other
treatments
available. CBER's review of new biological products, and for new indications for already approved products,
requires evaluating scientific and clinical data submitted by manufacturers to determine whether the
product
meets CBER's standards for approval. After a thorough assessment of the data, CBER makes a decision
based on the risk-benefit for the intended population and the product's intended use. Although medical
products are required to be safe, safety does not mean zero risk, since all medical products are associated
with some level of risk. A safe biological product is one that has reasonable risks, given the
patient's condition, the magnitude of the benefit expected, and the alternatives available. The choice
to use a
biological product involves balancing the benefits to be gained with the potential risks. CBER is committed
to a
product approval process that maximizes the benefits and minimizes the risks to patients of the biological
product.
Mission of the Laboratory:
To ensure the safety, purity, potency,
and effectiveness of biological products including vaccines, blood and blood
products, and cells, tissues, and gene therapies for the prevention, diagnosis, and treatment of human
diseases,
conditions, or injury. Through our mission, we also help to defend the public against the threats of
emerging
infectious diseases and bioterrorism. In fulfilling our mission as a Center in the U.S. Food and Drug
Administration, we apply the following principles with the highest ethical standards and integrity:
develop,
maintain, and support a high-quality and diverse workforce; ensure compliance with laws and regulations
through
review, education, surveillance, and enforcement; and conduct research as an essential element of science-
based decision-making.
Technology Transfer Mechanisms:
- Fellowships
- Cooperative Research and Development Agreements (CRADAs)
- Patents and Licensing
- Technical Assistance
Technology Areas of Expertise:
- Analytical Chemistry
- Biophysics
- Smallpox Vaccination
- Standards and testing
- Statistical methodology
- Vaccine Safety
- Vector borne viral diseases
- Viral products
- Enteric and sexually transmitted diseases
- Tumor vaccines and biotechnology
- Gene transfer and immunogenicity
- Hematology
- Hepatitis and related emerging agents
- Hepatitis viruses
- Methods development
- Methods of development and quality control
- Migration studies
- Molecular virology
- Mycobacterial diseases and cellular immunology
- Pediatric and respiratory viral diseases
- Pharmacogenomic and proteomic data analysis
- Plasma derivatives
- Respiratory and special pathogens
- Retrovirus research
