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Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / Notices
Center for Biologics Evaluation and
Research (HFM71), Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852,
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What is center for biologics evaluation?
The Center for Biologics Evaluation and Research (CBER) is a part of the U.S. Food and Drug Administration (FDA) that regulates biological products for human use.
Who is required to file center for biologics evaluation?
Any manufacturer of biological products for human use is required to file a center for biologics evaluation.
How to fill out center for biologics evaluation?
The center for biologics evaluation can be filled out online on the FDA's website and must include detailed information about the biological product.
What is the purpose of center for biologics evaluation?
The purpose of the center for biologics evaluation is to ensure the safety, purity, and potency of biological products for human use.
What information must be reported on center for biologics evaluation?
The center for biologics evaluation must include information on the manufacturing process, testing results, and labeling of the biological product.
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