A new drug application (NDA) containing full reports of safety and effectiveness studies conducted by the applicant.
An NDA that relies in part on data not developed by the applicant, such as published literature or FDA findings of safety and effectiveness for a previously approved drug.
The section of the FD&C Act governing Abbreviated New Drug Applications (ANDAs) for generic drugs.
A premarket submission demonstrating that a medical device is substantially equivalent to a legally marketed device not subject to PMA.
Abbreviated Antibiotic Drug Application. Historical application type for generic antibiotics, now covered under ANDA.
The process by which a drug moves from the site of administration into the bloodstream.
FDA program allowing earlier approval for drugs treating serious conditions based on surrogate endpoints.
Absorption, Distribution, Metabolism, Excretion. The four processes describing drug movement through the body.
Any undesirable experience associated with the use of a medical product in a patient.
Process of demonstrating that an analytical procedure is suitable for its intended purpose.
Abbreviated New Drug Application. An application for a generic drug product approval.
Active Pharmaceutical Ingredient. The biologically active component of a drug product.
Documentation of the production history of each batch of drug product, including manufacturing steps and testing.
Bioequivalence Study. Clinical study comparing the bioavailability of a test drug to a reference drug.
The rate and extent to which an active ingredient is absorbed and becomes available at the site of action.
The absence of a significant difference in bioavailability between two pharmaceutical equivalents.
A medical product derived from living organisms, including vaccines, blood products, and gene therapies.
A biological product highly similar to an already approved reference biologic with no clinically meaningful differences.
Biologics License Application. An application for approval of a biological product.
A procedure in clinical trials where participants and/or investigators do not know treatment assignments.
The strongest warning required by FDA, appearing in a box in the prescribing information for serious risks.
A designation for drugs intended to treat serious conditions where preliminary evidence shows substantial improvement over existing therapies.
Corrective and Preventive Action. A system for investigating deviations and implementing measures to prevent recurrence.
Center for Biologics Evaluation and Research. FDA center responsible for regulating biological products.
Center for Drug Evaluation and Research. FDA center responsible for regulating drugs.
Center for Devices and Radiological Health. FDA center responsible for regulating medical devices.
Code of Federal Regulations. The codification of rules published by federal agencies.
Current Good Manufacturing Practice. Up-to-date manufacturing standards ensuring drug quality and safety.
Medical devices with lowest risk, subject to general controls only.
Medical devices with moderate risk, subject to general and special controls.
Medical devices with highest risk, requiring premarket approval (PMA).
A characteristic or variable that reflects how a patient feels, functions, or survives in a clinical trial.
An FDA order to delay or suspend a clinical investigation due to safety or compliance concerns.
A research study that tests how well new medical approaches work in people.
Maximum Concentration. The highest plasma concentration achieved after drug administration.
Chemistry, Manufacturing, and Controls. The section of regulatory submissions describing drug substance and product manufacturing.
Contract Manufacturing Organization. A company that manufactures drug products for other companies.
Access to investigational drugs outside clinical trials for patients with serious conditions who have no alternatives.
FDA communication indicating that the review cycle is complete but the application cannot be approved in its current form.
A specific situation in which a drug should not be used because it may cause harm.
The group in a clinical trial that receives standard treatment or placebo for comparison.
Case Report Form. Document used to collect data for each clinical trial participant.
Complete Response Letter. FDA letter indicating application deficiencies that must be addressed before approval.
Contract Research Organization. A company that provides clinical trial and drug development support services.
Clinical Study Report. Comprehensive document describing the design, methods, and results of a clinical trial.
Common Technical Document. Standardized format for regulatory submissions accepted in ICH regions.
A regulatory pathway for novel low-to-moderate risk devices that lack a legally marketed predicate device.
A departure from approved procedures, specifications, or standards during manufacturing or testing.
The process by which a drug is transported from the bloodstream to tissues and organs.
Drug Master File. A submission to FDA containing confidential detailed information about a drug manufacturing facility.
The relationship between the dose of a drug and the magnitude of its effect.
A clinical trial design where neither participants nor investigators know treatment assignments.
A reaction between two or more drugs, or between a drug and food, that affects drug effectiveness or safety.
The finished dosage form containing the active pharmaceutical ingredient and excipients.
The active pharmaceutical ingredient (API) before formulation into the final drug product.
Drug Supply Chain Security Act. Law establishing requirements for tracking prescription drugs through the supply chain.
Data Safety Monitoring Board. Independent committee monitoring patient safety during clinical trials.
Electronic Common Technical Document. Electronic format for regulatory submissions.
The ability of a drug to produce the desired therapeutic effect under ideal conditions.
European Medicines Agency. Regulatory agency responsible for drug approval in the European Union.
A defined outcome measure used to assess the effect of a treatment in a clinical trial.
Emergency Use Authorization. Authorization for unapproved medical products during a public health emergency.
An inactive substance used as a carrier for the active ingredient in a drug formulation.
FDA-granted marketing protection preventing approval of competing applications for a specified period.
Pathways allowing patients with serious conditions to access investigational drugs outside clinical trials.
FDA Adverse Event Reporting System. Database of adverse event and medication error reports.
A designation to facilitate development and expedite review of drugs for serious conditions.
Federal Food, Drug, and Cosmetic Act. The primary law governing FDA regulation of drugs and devices.
Document listing observations of objectionable conditions found during FDA inspections.
The initial administration of an investigational drug to human subjects, typically in Phase I trials.
The process of combining active ingredients with excipients to create the final drug product.
Good Clinical Practice. International ethical and scientific quality standard for clinical trials.
Good Distribution Practice. Guidelines ensuring proper storage and transportation of pharmaceutical products.
Generic Drug User Fee Act. Authorizes FDA to collect fees from generic drug manufacturers.
A drug product that is equivalent to a brand-name drug in dosage, safety, strength, and intended use.
Good Laboratory Practice. Regulations governing non-clinical laboratory studies.
Good Manufacturing Practice. Regulations ensuring products are consistently produced and controlled.
The time required for the plasma concentration of a drug to decrease by half.
Legislation establishing the modern framework for generic drug approval and patent term restoration.
Humanitarian Device Exemption. FDA approval pathway for devices treating conditions affecting fewer than 8,000 patients annually.
International Council for Harmonisation. Organization developing pharmaceutical regulatory guidelines.
Investigational Device Exemption. Authorization to conduct clinical trials with an unapproved medical device.
Any component of a drug product that is not the active ingredient or an intended excipient.
Checks performed during manufacturing to monitor and ensure product quality.
Investigational New Drug. An application to begin human clinical trials.
The specific disease, condition, or symptom for which a drug is approved for treatment.
The process of providing participants with information about a clinical trial to enable voluntary participation decisions.
A biosimilar that may be substituted for the reference product without prescriber intervention.
Installation Qualification. Verification that equipment is properly installed according to specifications.
Institutional Review Board. Committee that reviews and monitors research involving human subjects.
Intent-to-Treat. Analysis including all randomized participants regardless of protocol adherence.
All written, printed, or graphic material accompanying a drug product, including the package insert.
Look-Alike Sound-Alike. Drugs with names or appearances that may be confused with other drugs.
Lethal Dose 50. The dose that causes death in 50% of test animals, used to measure acute toxicity.
A batch of drug product manufactured during a single production cycle with uniform characteristics.
Manufacturer and User Facility Device Experience. Database of medical device adverse event reports.
Medical Device Reporting. Requirements for manufacturers to report device-related adverse events to FDA.
Medical Device User Fee Act. Authorizes FDA to collect fees from medical device manufacturers.
FDA safety information and adverse event reporting program.
The chemical modification of drugs by the body, primarily in the liver, affecting drug activity and elimination.
A type of biologic made from identical immune cells, used to target specific proteins in disease treatment.
New Drug Application. Application for FDA approval to market a new drug.
New Molecular Entity. A drug containing an active moiety never before approved by FDA.
A clinical trial designed to show that a new treatment is not worse than an existing treatment by a specified margin.
Out of Specification. Test result falling outside established acceptance criteria.
Operational Qualification. Verification that equipment operates correctly within specified parameters.
FDA publication listing approved drug products with therapeutic equivalence evaluations.
A drug developed to treat a rare disease affecting fewer than 200,000 people in the US.
Over-the-Counter. Drugs available without a prescription.
Pre-Approval Inspection. FDA inspection of manufacturing facilities before drug approval.
ANDA certification that the generic drug will not infringe valid patents or that patents are invalid.
Extension of patent protection to compensate for time lost during FDA review.
An organized system collecting clinical data on patients with specific conditions.
Prescription Drug User Fee Act. Authorizes FDA to collect fees from drug manufacturers.
Additional six months of marketing exclusivity granted for conducting pediatric studies.
Progression-Free Survival. Time from treatment to disease progression or death, used as a clinical endpoint.
The study of the biochemical and physiological effects of drugs on the body.
The study of how the body absorbs, distributes, metabolizes, and excretes drugs over time.
The science of monitoring, detecting, and preventing adverse effects of pharmaceutical products.
First stage of clinical trials, testing safety, dosage, and side effects in a small group.
Second stage of clinical trials, testing efficacy and side effects in a larger group.
Third stage of clinical trials, confirming efficacy, monitoring side effects, and comparing to standard treatments.
Post-marketing studies to gather additional information about risks, benefits, and optimal use.
Principal Investigator. The lead researcher responsible for conducting a clinical trial at a site.
An inactive treatment used as a comparator in clinical trials to measure true drug effects.
Premarket Approval. The FDA process for evaluating Class III medical devices.
Pharmaceuticals and Medical Devices Agency. Regulatory agency responsible for drug approval in Japan.
Ongoing monitoring of drug safety after market approval to detect rare or long-term adverse effects.
A measure of drug activity expressed in terms of the amount required to produce a defined effect.
Performance Qualification. Verification that equipment consistently performs as intended under actual conditions.
Laboratory and animal studies conducted before human clinical trials to assess safety and activity.
A legally marketed device to which a new device is compared in a 510(k) submission.
FDA designation for drugs that offer significant improvements in treatment, diagnosis, or prevention.
Patient-Reported Outcome. Health outcomes reported directly by patients without interpretation.
Documented evidence that a manufacturing process consistently produces product meeting specifications.
A detailed plan describing the objectives, design, methodology, and analysis of a clinical trial.
Quality Assurance. Systematic activities ensuring quality requirements are fulfilled.
Quality by Design. Systematic approach to pharmaceutical development emphasizing understanding of product and process.
Quality Control. Testing and verification activities ensuring products meet specifications.
Qualified Infectious Disease Product. Designation for antibacterial or antifungal drugs providing additional incentives.
Quality Management System. Organizational structure and processes ensuring consistent quality.
Risk Assessment and Mitigation Planning. Process for identifying and managing drug development risks.
The process of assigning clinical trial participants to treatment groups by chance.
Randomized Controlled Trial. A clinical trial with random assignment to treatment or control groups.
Action to remove or correct a marketed product that violates FDA regulations.
The approved drug product to which generic versions are compared for bioequivalence.
Risk Evaluation and Mitigation Strategy. A drug safety program required by FDA.
The act of placing a drug product into a different container without altering the drug.
Authorization to rely on another party's data in a regulatory submission.
Evaluation comparing potential benefits of a treatment against its potential risks.
Real-Time Release. Testing approach using process data to release batches without traditional end-product testing.
Serious Adverse Event. An adverse event resulting in death, hospitalization, disability, or other serious outcomes.
The process of increasing batch size from laboratory or pilot scale to commercial production.
The period during which a drug product remains within approved specifications under stated storage conditions.
Any effect of a drug other than the intended therapeutic effect, whether harmful or not.
Standardised MedDRA Query. Grouping of related medical terms for safety analysis.
Supplemental New Drug Application. Application to modify an existing approved NDA.
Standard Operating Procedure. Written instructions describing how to perform specific tasks.
A list of tests, references to analytical procedures, and acceptance criteria for a product.
The entity responsible for initiating, managing, and financing a clinical trial or drug application.
Testing to determine how drug quality varies over time under different environmental conditions.
A result unlikely to have occurred by chance alone, typically p < 0.05.
The standard for 510(k) clearance showing a device is as safe and effective as a predicate.
A clinical trial designed to show that a new treatment is better than an existing treatment.
A biomarker intended to substitute for a clinical endpoint in assessing treatment benefit.
Suspected Unexpected Serious Adverse Reaction. A serious adverse reaction not listed in product information.
Drug products that are pharmaceutical equivalents and can be expected to have the same clinical effect.
The ratio between the toxic dose and therapeutic dose of a drug, indicating its safety margin.
Time to Maximum Concentration. The time required to reach peak plasma drug concentration.
The study of adverse effects of drugs and chemicals on living organisms.
Unique Device Identification. System for identifying medical devices through distribution and use.
United States Pharmacopeia. Organization setting standards for medicines.
Documented evidence that a process, system, or method consistently produces expected results.
FDA official correspondence notifying a company of significant regulatory violations.
Time between treatment phases in a clinical trial allowing prior drug effects to dissipate.