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