Skip to main content

FDA Category 2

Meaning

Within the context of drug development and regulatory science, “FDA Category 2” typically refers to a classification used by the U.S. Food and Drug Administration to denote a specific regulatory status or priority level for a drug application or a particular therapeutic area. In some older or internal guidance systems, it might signify drugs requiring a specific level of review intensity or a particular risk-benefit profile, such as those with moderate safety concerns. For a definitive clinical understanding, one must specify the exact FDA guidance document, as the agency utilizes various categorical systems for different purposes.