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Search Results

Blood
The FDA is responsible for ensuring the safety of our nation's blood supply. The CBER regulates the
collection of blood and blood components used for transfusion or for the manufacture of
pharmaceuticals derived from blood and blood components, such as clotting factors, and establishes
standards for the products themselves.
http://www.fda.gov/cber/blood.htm
Reviews Rating: Not yet Rated Whois Check

Allergenics
Regulates allergenic products. Site links to Advisory Committee meeting schedule and allergenics
policy guides.
http://www.fda.gov/cber/allergenics.htm
Reviews Rating: Not yet Rated Whois Check

Tissue
The CBER currently regulates human tissue intended for transplantation. Examples of such tissues
are bone, skin, corneas, ligament and tendon.
http://www.fda.gov/cber/tiss.htm
Reviews Rating: Not yet Rated Whois Check

Devices
The CBER regulates the medical devices involved in the collection, processing, testing, manufacture
and administration of licensed blood, blood components and cellular products. CBER also regulates
all HIV test kits.
http://www.fda.gov/cber/devices.htm
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Therapeutics
The Center regulates a variety of biological therapeutic products, as diverse as blood and blood
components; antitoxins; proteins generated by hybridoma or recombinant DNA technology; products
that consist of manipulated, cultured, or expanded human cells; vaccines directed against
non-infectious disease targets; and gene transfer products.
http://www.fda.gov/cber/therapies.htm
Reviews Rating: Not yet Rated Whois Check

Vaccines
The Center regulates vaccine products. Vaccines undergo a rigorous review of laboratory and
clinical data to ensure the safety, efficacy, purity and potency of these products. Major sections
are Flu Vaccine, Thimerosal, Anthrax, and Bovine Spongiform Encephalopathy, ("mad cow
disease.")
http://www.fda.gov/cber/vaccines.htm
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Electronic Freedom of Information Act Reading Room (EFOIA)
Provides access to all the documents posted on the CBER website. These documents are ones
frequently requested by the public through the Freedom of Information Act.
http://www.fda.gov/cber/reading.htm
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Licensed Product Information
Alphabetical list by the proper name of the product. Links to the approval letter, label and review
documents files for each product.
http://www.fda.gov/cber/efoi/approve.htm
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Center for Biologics Evaluation & Research (CBER)
Protects and enhances the public health through regulation of biological products including blood,
vaccines, therapeutics and related drugs and devices according to statutory authorities
http://www.fda.gov/cber/
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