Glossary of Terms Used by the FDA

The US Food and Drug Administration (FDA) uses specific terms related to their work or the work of scientists. Here is a look at some words and phrases you may see related to migraine research and treatment.

A to M

Adverse event: An adverse event is a harmful reaction to medical care, including medicine. You may also hear it called a side effect. You can have a mild adverse event or one that is more severe. Serious adverse events include disability, death, birth defects, and hospital stays.¹

Boxed warning: If a prescription drug raises your chance of serious harm or death, the FDA will issue a boxed warning. It is also frequently called a “black box warning” and is applied to the drug’s label.¹

ClinicalTrials.gov: On this website, you will find a list of clinical trials that researchers are carrying out globally. It is open to the public and managed by the National Library of Medicine at the National Institutes of Health.¹

Double-blind, randomized, controlled clinical trial: In this type of clinical trial, researchers split the people taking part into 2 groups. One group will get the treatment being studied. The other receives a standard treatment or nothing at all. Either way, participants do not know which group they are in. With this kind of study, researchers are more likely to avoid a placebo effect (placebo and placebo affect are explained below).¹

Medication guides: These are the leaflets you receive from your pharmacist that explain the risks of specific drugs and drug classes. The FDA approves the information on medication guides to help you avoid serious side effects.¹

Minimal risk: This term communicates that any harm or discomfort that may happen during research does not outweigh the kind you experience day-to-day or during standard physical or mental exams.¹

N to Z

New drug approval process: The FDA decides if a company can move forward from testing their drug in animals to testing it in humans. The company must share its findings with the FDA, which then looks at data on the drug’s safety and how well it works. The FDA weighs the drug’s benefits and risks before deciding whether to advance it to the next stage.¹

Off-label use: Off-label use is when your doctor prescribes an FDA-approved drug for you to use in a way that has not yet been studied.¹

Placebo: This is when researchers use a pill without medicine (also called a “sugar pill”). People who take part in clinical research will sometimes receive a placebo instead of active treatment.¹

Placebo effect: If you have received a placebo yet feel like you are benefiting from real treatment, experts call this a placebo effect. You may notice you “feel better” while overlooking any negative changes. The placebo effect can also impact researchers.¹

Post-market surveillance: After the FDA gives a drug the green light, they will continue to keep an eye on its safety. They are on the lookout for any problems they may have overlooked before approving the drug. Issues may also crop up with how people are using the drug or during the drug-making process.¹

Research: Scientists carry out research to answer a question. It means they are unclear which treatments will help people who are ill. Research is also called a clinical trial, protocol, study, or experiment.¹