Biologic: medicine made by biological processes rather than by chemical synthesis or extraction. Biologics typify biotechnology-derived drugs. Contrast with small-molecule drugs.

Biologics License Application (BLA): application filed with the FDA Center for Biologics Evaluation and Research (CDER) for approval to market a biologic drug.

Brand-name drug: the patented version of a drug. Contrast with generic drugs.

Clinical pharmacology study: clinical trial designed to determine the absorption, distribution, metabolism, elimination, and toxicity (ADMET) of a drug.

Clinical trial: human study designed to measure the safety and efficacy of a new drug.

Exclusivity: a temporary FDA-granted monopoly, distinct from patent or other intellectual property protection. Exclusivity may be granted for developing drugs for rare diseases, novel drugs, conducting pediatric clinical trials, or successfully challenging invalid patents.

Fast Track: a process for interacting with the FDA during drug development, intended for drugs to treat serious or life threatening conditions that demonstrate the potential to address an unmet medical need.

First-in-man study: Phase I trial primarily concerned with establishing the safety of a compound.

Generic drug: the version of an approved drug produced by a competitor after a pioneer firmís patents expire.

Hatch-Waxman Act: contains provisions to foster the development of generic drugs and support pioneer drug development.

Institutional Review Board (IRB): an independent committee of scientists, physicians, and lay people that oversees clinical trials.

Investigational New Drug (IND): an application to pursue clinical trials with an experimental drug that has passed pre-clinical trials.

New Drug Application (NDA): application filed with the FDA Center for Drug Evaluation and Research (CDER) for approval to market a small-molecule drug.

Off-label use: Use of a drug not in accordance with FDA-approved uses or drug labelling. Physicians are free to use drugs for off-label uses.


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