What is the role of the FDA in biotechnology?

The FDA, or the Food and Drug Administration, plays a crucial role in the biotechnology sector primarily through its responsibility to regulate and approve biotechnological products. This involves ensuring the safety, efficacy, and security of biologics, including vaccines, blood products, and gene therapies, before they are allowed to enter the market.

This regulatory process includes rigorous evaluations of clinical trial data, manufacturing practices, and labeling, among other criteria, to protect public health. The FDA's oversight helps to maintain high industry standards and instills confidence in consumers about the products they receive. The FDA does not engage in the development or manufacturing of biotechnological products nor does it directly fund research, as those functions are typically carried out by private companies or research institutions. Thus, the FDA's primary function is focused on regulation and approval within the realm of biotechnology.