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What is the difference between CBER and CDER?

CDER is the lead Center for regulation of human drugs that are regulated by FDA under the authority of the Federal Food Drug and Cosmetic (FDC) Act. Drug products are defined in section 201(g) of the FDC Act. CBER is the lead center for regulating biological products. Intercenter Agreement Between the Center for Drug - FDA Food and Drug Administration (.gov) jurisdictional-information interc Food and Drug Administration (.gov) jurisdictional-information interc

What is the purpose of the CBER?

The mission of the Center for Biologics Evaluation and Research (CBER) is to ensure the safety, purity, potency, and effectiveness of biological products including vaccines, allergenics, blood and blood products, and cells, tissues, and gene therapies for the prevention, diagnosis, and treatment of human diseases,

What is one of the tasks performed by the FDAs Center for Drug Evaluation and Research?

Responsibilities. CDER reviews New Drug Applications to ensure that the drugs are safe and effective. Its primary objective is to ensure that all prescription and over-the-counter (OTC) medications are safe and effective when used as directed. The FDA requires a four-phased series of clinical trials for testing drugs. Center for Drug Evaluation and Research - Wikipedia wikipedia.org wiki CenterforDrugEvalu wikipedia.org wiki CenterforDrugEvalu

What does the Center for Drug Evaluation and Research regulate?

As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines. For example, fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens are all considered drugs. Center for Drug Evaluation and Research | CDER - FDA fda.gov about-fda fda-organization ce fda.gov about-fda fda-organization ce

What is CBER responsible for?

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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