Skip to main content

Biologics Approval Pathway

Meaning

The Biologics Approval Pathway denotes the specific regulatory process established by governing bodies, such as the FDA, for reviewing and authorizing biological products intended for clinical use. Biologics, unlike small-molecule drugs, are complex medicinal products derived from living organisms, including therapeutic proteins, hormones, and vaccines. This pathway ensures that these complex molecules meet stringent standards for safety, purity, and potency before they can be introduced into human physiology. It represents the critical validation step necessary to integrate novel biological therapies into hormonal health protocols.