Compare and contrast the manner in which CBER regulates pre-clinical and clinical investigation of biologic products...

Compare and contrast the manner in which CBER regulates pre-clinical and clinical investigation of biologic products with the way CDER regulates pre- clinical and clinical investigation of drugs.

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Expert Solution

Center for Biologics Evaluation and Research (CBER) is one of the six main centers of USFDA. The CBER regulates the use of biologics. The scope includes the regulation of:

1. Blood and plasma derivatives

2. Vaccines

3. Diagnostic and therapeutic extracts

4. Human cells and tissues

5. Xenobiotics

Center for Drugs Evaluation and Research (CDER) is one of the six main centers of USFDA. The CBER regulates the use and sale of drugs. The scope includes the regulation of:

1. the safety of the drugs

2. the efficacy of the drugs

3. Decide which drugs are to be sold strictly upon prescription.

4. ensure new drugs have undergone phase I through phase IV trials.

gladiator answered 1 year ago

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