Industry Jargon

Endpoint

Event or outcome measured by a clinical trial that is used to find out whether the drug being studied is beneficial

Contract Research

Investigational New Drug (IND)

New Drug Application (NDA)

Biologics License Applications

Code of Federal Regulations (CFR)

Good Clinical Practice (GCP)

An outside company that offers clinical trial, manufacturing, and testing services, usually to larger pharmaceutical companies

An application to the FDA to begin testing a new drug in humans. It includes study data and a clinical trial plan (protocol)

An application to the FDA to get approval to market a new drug in the United States. It includes study data and information on the drug’s safety and effectiveness.

An application to the FDA to market a biological product. It includes information on the product’s safety, effectiveness, and how it is made.

Rules set by the FDA to ensure that drugs are made and controlled in a way that guarantees their strength, quality, and purity.

An international set of regulations that ensures the results and process of a clinical trial are reliable so that patients are protected

When learning about the pharmaceutical industry, it’s easy to get lost in the many acronyms and jargon in presentations, job applications, and resources. As a student, I’ve felt the need to compile a list of some of key pharmaceutical industry definitions to help you better understand an area in the industry.