Overview
While some biologics are intended to treat diseases and medical conditions, others are designed to prevent or diagnose diseases. The therapeutic biological products (TBPs) regulated by the Center for Drug Evaluation and Research (CDER) of the U.S. FDA typically refer to the following…
Drugs and medical devices represent two modalities in treating disease, which display some fundamental differences. Drug molecules, when administered by conventional means, rarely remain in the body at therapeutic levels for extended time periods. Implantable devices such as…
