Reference

Glossary

Definitions of medical and FDA terms used across MedivaScan. Each entry is quoted verbatim from a public FDA, openFDA, or NLM source with citation and last-verified date.

A

Abbreviated New Drug Application (ANDA): An Abbreviated New Drug Application (ANDA) is the submission a generic drug sponsor files with the FDA to seek approval to manufacture and market a generic version of an already approved drug.
Active Ingredient: The component of a drug product responsible for its pharmacological activity or direct effect in diagnosing, treating, or preventing disease.
Adverse Event Report: An adverse event report documents an undesirable experience associated with the use of a medical product in a patient, submitted to the FDA when specific serious outcomes occur.

B

Boxed Warning: A boxed warning is the most prominent safety alert the FDA can require on a prescription drug label, used to flag contraindications or serious risks that may lead to death or serious injury.
Brand-Name Drug: A brand-name drug is a medication sold under a proprietary, trademark-protected name held by its manufacturer.

C

Class I Recall: A Class I recall is the most serious FDA recall classification, applied when a violative product is judged likely to cause serious health consequences or death.
Class II Recall: A Class II Recall is an FDA recall classification used when a violative product may cause temporary or medically reversible adverse health effects, or when the probability of serious harm is considered remote.
Class III Recall: A Class III Recall is the lowest-severity category in the FDA recall classification system, applied when a violative product is not likely to cause adverse health consequences.
Contraindication: A situation in which a drug should not be used because the known risk of harm clearly outweighs any possible therapeutic benefit. FDA labeling requires this section to list only known hazards, not theoretical risks.
Cytochrome P450 Enzymes (CYP)Tier 2: A family of liver-based enzymes that metabolize most drugs and many endogenous compounds. CYP activity influences how drugs are cleared from the body and is a common site of drug interactions.

D

DailyMed: DailyMed is a U.S. National Library of Medicine database that publishes current FDA labeling submitted by manufacturers for prescription drugs, biologics, OTC products, and other regulated items.
Drug HypersensitivityTier 2: Drug hypersensitivity refers to allergic reactions to a medication, producing a group of immune-related symptoms after exposure to the drug.
Drug Interaction: A clinically significant effect that occurs when a drug is taken with another prescription medication, over-the-counter product, drug class, or food. FDA-approved labeling describes known or predicted interactions and how to manage them.
Drug Shortage: A drug shortage is a period when nationwide supply of a drug does not meet, or is not projected to meet, current or projected demand in the United States.

F

FDA Adverse Event Reporting System (FAERS): A U.S. Food and Drug Administration database that collects reports of adverse events and medication errors submitted for FDA-regulated products. FAERS supports postmarket safety surveillance.
FDA Approval: FDA approval is the U.S. Food and Drug Administration's authorization that a drug has met federal standards for safety and effectiveness before it can be marketed in the United States.
FDA-Approved Label: The FDA-approved label is the official document accompanying a drug product that describes its approved uses, dosing, safety information, and population-specific instructions.

G

Generic Drug: A generic drug is a medication that matches a brand name drug in active ingredient, dosage, strength, route, quality, performance, and intended use, and is reviewed by FDA for therapeutic equivalence.

H

Half-Life (Elimination)Tier 2: Elimination half-life is the time required for the concentration of a substance, typically a drug, to fall to half of its initial amount in the body.

I

Indication: An indication is the specific disease, condition, symptom, or manifestation for which a drug is approved for use, as stated in the FDA-approved labeling.
Investigational New Drug (IND)Tier 2: An Investigational New Drug (IND) is the regulatory mechanism by which a sponsor obtains FDA permission to ship an unapproved drug across state lines for use in clinical investigations.

L

Long QT SyndromeTier 2: Long QT Syndrome is a cardiac condition, congenital or acquired, in which the QT interval on an electrocardiogram is prolonged, raising the risk of arrhythmias.

M

MedWatchTier 2: MedWatch is the FDA program that collects safety reports on medical products from healthcare professionals, patients, and consumers.

N

National Drug Code (NDC): The National Drug Code (NDC) is the FDA identifier for finished and unfinished drugs listed by labelers in structured product labeling files. It is maintained in the FDA NDC Directory.
New Drug Application (NDA): A New Drug Application (NDA) is the formal submission a drug sponsor sends to the FDA to request approval to market a new drug in the United States.

O

openFDA: openFDA is a U.S. Food and Drug Administration initiative that provides public, machine-readable access to FDA datasets, including drug labeling, adverse event reports, and recall records.

P

PharmacodynamicsTier 2: Pharmacodynamics is the branch of pharmacology concerned with how a drug acts on the body, including its biochemical and physiological effects and the mechanisms behind those effects.
PharmacokineticsTier 2: Pharmacokinetics (PK) is the study of how the body processes a drug across absorption, distribution, metabolism, and excretion (ADME).
Pharmacologic Class: A grouping of active drug ingredients that share documented scientific properties, used by the FDA to categorize medications by shared characteristics.

R

Recall: A recall is a firm's removal or correction of a marketed product that FDA considers to be in violation of the laws it administers. It is distinct from a market withdrawal or stock recovery.
Recall Classification: Recall classification is the numerical designation (I, II, or III) the FDA assigns to a product recall to indicate the relative degree of health hazard the recalled product presents.
Risk Evaluation and Mitigation Strategies (REMS)Tier 2: A Risk Evaluation and Mitigation Strategy (REMS) is an FDA-required drug safety program designed to manage known or potential serious risks associated with certain medications.

T

Therapeutic Equivalence (TE): A U.S. Food and Drug Administration classification indicating that two drug products can be substituted for one another with the expectation of the same clinical effect and safety profile.

For information only. MedivaScan summarizes public FDA data and is not medical advice. Consult a healthcare professional before changing any medication. If you experience a serious reaction, contact your doctor or call 911.