Which of the following would qualify as a biologic according to FDA definitions?

The classification of biologics by the FDA includes products that are derived from living organisms and can include a range of products such as therapeutic serums and vaccines. These products typically involve complex mixtures that may include proteins, nucleic acids, or cells, and they are often used for therapeutic purposes, including prevention, diagnosis, and treatment of diseases.

Therapeutic serums and vaccines play a crucial role in medicine, as they are designed to elicit immune responses or provide passive immunity against specific diseases. The FDA specifically regulates these types of products under the Public Health Service Act (PHS Act) and the Federal Food, Drug, and Cosmetic Act (FDCA), which sets them apart from conventional drugs that are typically composed of chemical compounds.

In contrast, synthetic polymers and manufactured drugs with chemical compounds do not fit the definition of biologics, as they are not derived from living organisms. A substance that requires no regulatory oversight does not meet the criteria set by the FDA for either biologics or other regulated products, as all medical products intended for use in humans must undergo some level of regulatory scrutiny to ensure their safety and effectiveness. Thus, the only choice that aligns with the FDA's definition of biologics is the therapeutic serum or vaccine.