Medical Product Regulation: Drugs, Biologics, and Devices.

The article focuses on the regulation of medical products, including drugs, biologics and devices, by the Food and Drug Administration (FDA). It explains the premarket requirements for drugs and biologics, such as submission of a biologics license application (BLA), and the different pathways for approval. It also discusses the premarket requirements for medical devices based on their risk classification and the postmarket requirements for all medical products.