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Which of the following agencies is responsible for establishing and maintaining the safety purity and potency of biological products for human use?

FDA Review Whether the methods used to manufacture the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity.

What is biologic product?

Biological products are a diverse category of products and are generally large, complex molecules. These products may be produced through biotechnology in a living system, such as a microorganism, plant cell, or animal cell, and are often more difficult to characterize than small molecule drugs.

What products does CBER regulate?

CBER regulates an array of diverse and complex biological products, both investigational and licensed, including: allergenics, blood and blood components, medical devices and tests, gene therapy, human tissues and cellular products, vaccines, and xenotransplantation products.

What is BPDR FDA?

Biological Product Deviation Reporting (BPDR) CBER Contact Information.

What does the Center for Biologics Evaluation and Research do?

CBER is the Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act.

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What is a deviation FDA?

A deviation is a measured difference between a normal or expected value and an observed value for a pharmaceutical product or process. It can also be a noted departure from a documented or standard procedure.

What report must be submitted if an error could affect the safety potency or purity of a distributed blood product?

Under 21 CFR 606.171(b), you must submit a report when there is an event (a deviation or unexpected or unforeseeable event) in donor record documentation that may affect the safety, purity, or potency of a product you distributed.

What does CDER regulate?

The Center oversees the research, development, manufacture and marketing of drugs. CDER ensures truth in advertising for prescription drugs and monitors the use of marketed drugs for unexpected health risks.

Are blood transfusions FDA approved?

FDA regulations require that a donor be free from any disease transmissible by blood transfusion, in so far as can be determined by health history and examination. Donors are informed about potential risks and are required to answer questions about factors that may have a bearing on the safety of their blood.

What is a deviation FDA?

A deviation is a measured difference between a normal or expected value and an observed value for a pharmaceutical product or process. It can also be a noted departure from a documented or standard procedure.

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Which of the following agencies is responsible for establishing and maintaining the safety purity and potency of biological products for human use?

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