The Biologics Industry: How Federal Regulation Enhances Quality of Vaccine and Antibody Manufacture

Abstract

Credit — This lesson is good for 0.2 CE units, with a passing grade of 70%.

Objectives

1. Describe the historical development of federal regulations that affect manufacture of vaccines and antibodies.

2. Describe the procedures used by the Food and Drug Administration (FDA) to enhance manufacturing quality.

3. List examples of actions FDA may take to deal with substandard products or procedures.

Keywords

vaccines antibodies biologics manufacturing regulation laws

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