Glossary Terms

An FDA mechanism that permits the use of unapproved medical products—or unapproved uses of approved products—during declared public health emergencies […]

The regulatory pathway for seeking FDA approval of a generic drug product. An ANDA applicant must demonstrate that its product

A Risk Evaluation and Mitigation Strategy is an FDA-mandated safety program required for certain drugs whose benefits justify their availability

The FDA’s official registry of drugs currently in shortage, maintained under the Federal Food, Drug, and Cosmetic Act. When a

The Drug Quality and Security Act of 2013, enacted in response to the 2012 New England Compounding Center meningitis outbreak

A regulatory mechanism in which the product of a biological process inhibits further production of that product, maintaining homeostasis. The

The physiological pattern of growth hormone (GH) secretion, in which the pituitary gland releases GH in discrete pulses rather than

A large glycosaminoglycan (sugar-based molecule) that is a major component of the extracellular matrix in skin, synovial fluid (joints), and

A highly durable, elastic protein that gives tissues their ability to stretch and recoil. Elastin is abundant in skin, blood

The multi-step biological process by which fibroblasts and other cells produce collagen, the most abundant protein in the human body.