CBER:

One of 6 main centers of USFDA.

Regulates biological products for human use under applicable federal laws, including the
Public Health Service Act and the Federal Food, Drug and Cosmetic Act.
Responsible for assuring the safety, purity, potency, and effectiveness of biologics and
related products (such as vaccines, live biotherapeutics (probiotics), blood products, and
cell, tissue, and gene therapies).
Monoclonal antibodies and other therapeutic proteins are regulated by the FDA Center
for Drug Evaluation and Research (CDER).
 Biological Products:

Derived from human, animals, plants and microorganism sources.

This includes blood and blood components, tissues allergenic extracts, vaccines, drugs
derived using biotechnology and certain diagnostic products.
 Regulating the products:

Activities includes:
Monitoring the pre-clinical and clinical testing of new biological products, and evaluating their
safety and effectiveness before marketing.
Licensing biological products and manufacturing establishments, including blood banks.
Research on aids medications, diagnostic tests, and vaccines.
Compliance monitoring, lot releasing, and post market surveillance.
 Approval:

CBER staff reviews clinical research and laboratory testing data to determine if the biologic is safe
and effective for its intended use.
In order for a biological product to be approved for marketing in the U.S., an applicant must
submit a Biologics License Application (BLA).
 BLA:

Animal studies and human clinical trials performed

How the biologic is manufactured, processed, and packaged, including information on the quality
control methods used during its manufacture
Labeling that will be used with the product
Once a biological product is approved, its identity and manufacturing process cannot change without
prior FDA approval.
Blood Supply:

A ing he afe of, and he p blic confidence in, he na ion blood ppl i one of cbe
main priorities. There are five overlapping safeguards in place to help protect the safety of
blood.
Quarantine of untested blood
Donor screening
Donor deferral registries
Blood testing
Investigations of problems
Some of the products regulated by CBER are devices.
These include products used in the collection and processing of blood products, such as
blood bags, centrifuges, and test kits that are used to screen donated blood for infections
diseases such as hiv and hepatitis.
 Authority:
Resides in section 351 and 361 of the Public Health Service Act.

Section 351:
Licensing the biological products that travel in the interstate commerce of the
United States.
Deny or suspend or cancel any current license if the manufacturer does not
comply with the requirements.

Section 361:
Make and enforce the regulations to control the interstate speed of
communicable diseases.