Describe the regulatory process

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Reference no: EM133875641

Question

Transfusion Safety and Regulations

1. Describe why laws governing the regulation of biological products were enacted.

2. Define a biological product manufacturer.

3. Describe the regulatory process.

4. List the requirements for and responsibilities of being registered with the US Food and Drug Administration (FDA).

5. List the requirements for and responsibilities of FDA licensure.

6. Describe the FDA's inspectional authority of biological product manufacturers.

7. Describe the role of the US Food and Drug Administration's current good manufacturing practice (CGMP) in biological product manufacturing.

8. List the possible enforcement actions.

9. List the FDA's five layers of safety for protecting the blood supply.

Reference no: EM133875641

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