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fda glossary of terms

ofloxacin listen (oh-FLOK-suh-sin) An antibiotic drug used to treat infection. Chemical TypeThe Chemical Type represents the newness of a drug formulation or a new indication for an existing drug formulation. Over-the-Counter Drugs (OTC)FDA defines OTC drugs as safe and effective for use by the general public without a doctor's prescription. The drug company submits the results of such studies to FDA for review. Form FDA 3926 - Used by physicians when submitting requests for expanded access to investigational drugs, including emergency requests. Sodium - an element that the body needs to work properly. Companies are allowed to make changes to drugs or their labels after they have been approved. More than almost 25,000 FDA terms and codes are stored in NCI Thesaurus (NCIt). NDA = New Drug Application. [Main Principles for Pharmaceutical Products, WHO] Experiment - A study done to answer a question. It is a daily (except federal holidays) publication. Sodium is also needed for your muscles and nerves to work properly. Post-market surveillance looks to identify problems that were not observed or recognized before approval and any problems that may arise because a drug may not be used as described in the drug labeling, or because a drug is being manufactured incorrectly. Participants are assigned to a group based on chance, not choice. Labels are often found inside drug product packaging. Healthy volunteer - In a clinical study, a person who does not have the disorder or disease being studied. Biologic License Application (BLA)Biological products are approved for marketing under the provisions of the Public Health Service (PHS) Act. Drug products evaluated as "therapeutically equivalent" can be expected to have equal effect and no difference when substituted for the brand name product. The objective of FDA regulatory programs is to ensure compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). An in vitro test is one that is done in glass or plastic vessels in the laboratory. In Drugs@FDA, you can find the NDA number under the column named "FDA Application.". Clinical Trial. Glossary of Medical Device Industry Terms. Approval Letter An official communication from FDA to a new drug application (NDA) sponsor that allows the commercial marketing of the product. This is called a “placebo effect.” For example, if a participant feels hopeful about a treatment, he or she may be more likely to notice positive changes than negatives ones. The RxList drug medical dictionary contains definitions and explanations of many medical terms including prescription medication abbreviations. Informed consent - When a participant provides informed consent, it means that he or she has learned the key facts about a research study and agrees to take part in it. For more detailed information, see the “What is informed consent?” section in this guide. Brief Summary. (List of Review Classifications and their meanings). The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Terms and Acronyms This glossary provides brief descriptions of selected terms and concepts related to the pharmaceutical industry. The Drug Facts tell you what a medicine is supposed to do, who should or should not take it, and how to use it. Glossary; Glossary. Unlike people with type 1 diabetes, the bodies of people with type 2 diabetes make insulin. Scientists do research when they’re not sure what will work best to help people with an illness. Welcome to the Drugs@FDA glossary of terms. Supplement Type Companies are allowed to make changes to drugs or their labels after they have been approved. Glossary of Terms Search: # ... legal use of a prescription drug to treat a disease or condition for which the drug has not been approved by the U.S. Food and Drug Administration. A    B    C    D    E    F    G    H    I    J    K    L    M    N    O    P    Q    R    S    T    U    V    W    X    Y    Z. Abbreviated New Drug Application (ANDA) An Abbreviated New Drug Application (ANDA) contains data that, when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Therefore, they may be effective in the treatment of a condition, or they may not. There are over 50 kinds of approval actions including changes in the labeling, a new route of administration, and a new patient population for a drug product. Protocol - A study done to answer a question. Therefore, they may be effective in the treatment of a condition, or they may not. Biologics are isolated from a variety of natural sources — human, animal, or microorganism — and may be produced by biotechnology methods and other cutting-edge technologies. By law, a generic drug product must contain the identical amounts of the same active ingredient(s) as the brand name product. Synergy – when two or more drugs are taken together; the combined action increases the normal effect of each drug. To gain access to an investigational medical product outside of a clinical trial, the sponsors must decide whether to make their experimental medical product available to patients via expanded access.  FDA regulations specify two groups of people eligible for expanded access: those with life-threatening diseases or conditions for which “there is a reasonable likelihood that death will occur within a matter of months or in which premature death is likely without early treatment”, those with serious diseases or conditions that have a “substantial impact on day-to-day functioning”. Scientists are trying to prove in clinical trials: How the drug might be used in that disease. Information about the potential benefits and risks of taking the drug. Active Ingredient An active ingredient is any component that provides pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or animals. Serious adverse events are those that can cause disability, are life-threatening, result in hospitalization or death, or are birth defects. RouteA route of administration is a way of administering a drug to a site in a patient. The agency conducts a thorough review of the safety and effectiveness data, and considers how the benefits compare to the risks when making a decision of whether or not to approve a drug. "Off Label Use" - also called unapproved use of an approved product, is when your healthcare provider uses an FDA-approved medical product for a use that has not been studied yet. The 1984 Drug Price Act extended patent terms to account for the time it took a drug to receive FDA approval, and it reduced the barriers to entry for generic drug producers by allowing them to assert safety and efficacy based on information in the original NDA and on a proof that the original drug and generic drug are bioequivalent. Strength The strength of a drug product tells how much of the active ingredient is present in each dosage. Minimal Risk - means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. NIH scientists investigate ways to prevent disease as well as the causes, treatments, and even cures for common and rare diseases. ClinicalTrials.Gov - is an online registry of clinical trials that are being conducted around the world.  ClinicalTrials.gov is operated by the National Library of Medicine at the National Institutes of Health and can be accessed by anyone who has access to the internet. But either their pancreas does not make enough insulin or the body cannot use the insulin well enough. What Are the Different Types of Clinical Research? A conclusion that a drug should no longer be marketed is based on the nature and frequency of the adverse events and how the drug’s benefit and risk balance compares with treatment alternatives. Adverse events can range from mild to severe. The researcher cannot use a different method for you. 504: Rural Housing Repair and Rehabilitation Program 2501: Outreach and Technical Assistance for Socially Disadvantaged and Veteran Farmers and Ranchers Program 9003: Biorefinery Assistance Program 9004: Repowering Assistance Program 9005: Advanced Biofuel Payment Program 1862s: Land-Grant Institutions Established by the Passage of the First Morrill Act (1862) Supplement A supplement is an application to allow a company to make changes in a product that already has an approved new drug application (NDA). Research - A study done to answer a question. Office of Minority Health (FDA) - was established in 2010. OMH serves as the principal advisor to the Commissioner on minority health and health disparities. The Office provides leadership and direction in identifying agency actions that can help reduce health disparities, including the coordination of efforts across the Agency. New Drug Application (NDA) Number This six digit number is assigned by FDA staff to each application for approval to market a new drug in the United States. If the NDA is approved, the product may be marketed in the United States. It is not intended to be a comprehensive list of relevant terms or to provide a complete explanation of the included terms and concepts. [ICH Q6B] Measurable terms under which a test result will be considered acceptable. A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. Glucose is a form of sugar your body uses for energy. Adverse Event - drug reaction is also known as a side effect, is any undesirable experience associated with the use of a medicine in a patient. By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. Results from healthy controls are compared to results from the group being studied. Sample TE codes: AA, AB, BC (More on TE Codes). A biologics license application is a submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product. There are literally hundreds of slang terms or street names for marijuana or cannabis, … Supplement Number A supplement number is associated with an existing FDA New Drug Application (NDA) number. 123 ... with the Food and Drug Administration (FDA). Confidentiality regarding participants - This refers to the practice of maintaining as private all information related to clinical trial participants, including their personal identity and all personal medical information. Addiction: A chronic, relapsing disorder characterized by compulsive (or difficult to control) drug seeking and use despite harmful consequences, as well as long-lasting changes in the brain. Patient Package Insert (PPI)A patient package insert contains information for patients' understanding of how to safely use a drug product. In general, the term "drugs" includes therapeutic biological products. This includes changes in manufacturing, patient population, and formulation. Randomization/random assignment - This is the process in which researchers evenly assign study participants into a group receiving the experimental treatment being studied, and others into a group receiving standard or no treatment. Privacy Policy - We have a strict privacy policy. CMI sheets are not developed or regulated by FDA. A drug can have more than one application number if it has different dosage forms or routes of administration. Listed here are examples of some common terms for various commodity areas and their plain language definitions. Qualitative Test Result: A test result expressed in non-numerical terms in order to determine the presence or absence of drug or drug metabolite in the sample. If the information provided meets FDA requirements, the application is approved and a license is issued allowing the firm to market the product. Standardized procedures - These are study rules that researchers must follow exactly for every participant, regardless of what each participant is used to. CDER must approve all important NDA changes (in packaging or ingredients, for instance) to ensure the conditions originally set for the product are still met. A researcher’s hope may also sway a participant’s response. A substance intended for use as a component of a medicine but not a device or a component, part or accessory of a device. In vitro is the opposite of in vivo. For example, an experiment that is done in vivo is done in the body of a living organism. The tentative approval letter details the circumstances associated with the tentative approval. Glossary: FDA The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food … Adverse Event - drug reaction is also known as a side effect, is any undesirable experience associated with the use of a medicine in a patient. It is a comprehensive analysis of clinical trial data and other information prepared by FDA drug application reviewers. Researchers compare results from the control group with results from the experimental group to find and learn from any differences. ... Food and Drug Administration. An official website of the United States government, : Members of the research team regularly monitor the participant’s health to determine the study’s safety and effectiveness. February 2, 2016; FDA News; On January 28, 2016, an FDA and NIH Joint Leadership Council published its first official glossary of terms and definitions, which “clarifies important definitions and describes some of the hierarchical relationships, connections, and dependencies among the terms it contains.”. ABHI – Association of British Healthcare Industries. Biological products are included within this definition and are generally covered by the same laws and regulations, but differences exist regarding their manufacturing processes (chemical process versus biological process. FDASIA Section 907 - directed FDA to report on the extent to which demographic subgroups (sex, age, race and ethnicity) participate in clinical trials in marketing applications for drugs, biologics, and devices. Inclusion/exclusion criteria - are the factors that allow someone to participate in a clinical trial. Standard treatment - The treatment that medical professionals consider at the time of the study to be the most prevalent and best available treatment. Abbreviated New Drug Application (ANDA) Number This six-digit number is assigned by FDA staff to each application for approval to market a generic drug in the United States. Composed of 27 Institutes and Centers, NIH provides leadership and financial support to researchers in every state and throughout the world. Single-blind research design - A study in which one party, either the investigator or participant, is unaware of what medication or intervention the participant is taking; also called single-masked study. Neither group knows how it has been assigned. Always contact an experienced criminal defense lawyer if you have been charged with a drug crime offense, or if you believe you are under investigation for drug crime. Glossary of Terms Learn “FDA-Speak” The Food and Drug Administration has its own set of unique terminology, definitions, and regulatory requirements. Tentative Approval If a generic drug product is ready for approval before the expiration of any patents or exclusivities accorded to the reference listed drug product, FDA issues a tentative approval letter to the applicant. Boxed Warning - This type of warning is also commonly referred to as a “black box warning.” It appears on a prescription drug’s label and is designed to call attention to serious or life-threatening risks. Placebo - An inactive pill. There are no copyright restrictions on the Federal Register; as a work of the U.S. government, it is in the public domain. Each sNDA is assigned a number which is usually, but not always, sequential, starting with 001. A substance recognized by an official pharmacopoeia or formulary. CompanyThe company (also called applicant or sponsor) submits an application to FDA for approval to market a drug product in the United States. The letters educate healthcare professionals about new and important drug information. Drug Approvals and Databases, Recalls, Market Withdrawals and Safety Alerts, Resources for Information | Approved Drugs, list of Chemical Types and their meanings, List of Review Classifications and their meanings. Therapeutic Biological ProductA therapeutic biological product is a protein derived from living material (such as cells or tissues) used to treat or cure disease. Generic Drug A generic drug is the same as a brand name drug in dosage, safety, strength, how it is taken, quality, performance, and intended use. Institutional Review Board- As defined in the Code of Federal Regulations Title 21 Part 56 means any board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of, biomedical research involving human subjects. In addition, the Library coordinates a 6,000-member National Network of Libraries of Medicine that promotes and provides access to health information in communities across the United States. Drug Product The finished dosage form that contains a drug substance, generally, but not necessarily in association with other active or inactive ingredients. Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available. AAC: Actual Acquisition Cost. Drug products in Drugs@FDA are identified as: Medication Guide A medication guide contains information for patients on how to safely use a drug product. Code of Federal Regulations Title 21 Part 56. In vitro - In glass, as in a test tube. Abbreviated New Animal Drug Application (ANADA) An application made to CVM (FDA) for approval of a generic animal drug. (list of Chemical Types and their meanings). New Drug Approval Process - After the animal testing stage, FDA decides whether it is reasonably safe for the company to move forward with clinical trials—studies that evaluate the safety and effectiveness of a drug in healthy people and in patients. FDA delays final approval of the generic drug product until all patent or exclusivity issues have been resolved. An application by a company to the FDA to market a drug. FDA Action Date The action date tells when an FDA regulatory action, such as an original or supplemental approval, took place. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). Instead, a generic applicant must scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the innovator drug). Letters to Health Care Professionals - often referred to as “Dear Doctor” letters—that are developed by drug companies often with input from FDA. These are proteins derived from living material (such as cells or tissues) used to treat or cure disease. Patient Network News - This bi-weekly newsletter provided by the Office of Health and Constituent Affairs is intended to inform you of current FDA-related information on medical product: *approvals *labeling changes *safety warnings *ways to participate on upcoming public meetings *ways to comment on proposed regulatory guidances *other information of interest to patients and patient advocates. Investigational drugs and devices have not yet been approved by the FDA and they have not been proven to be safe and effective. Before sharing sensitive information, make sure you're on a federal government site. The .gov means it’s official.Federal government websites often end in .gov or .mil. More information on FAERS. Control group - The group of participants that receives standard treatment or a placebo. This practice reduces the chance for a “placebo effect,” in which a treatment with no active ingredient produces results expected from a treatment with an active ingredient. Glossary of clinical trial terms. Type 1 Diabetes - Diabetes mellitus type 1 (also known as type 1 diabetes, or T1DM; formerly insulin dependent diabetes or juvenile diabetes) is a form of diabetes mellitus that results from the autoimmune destruction of the insulin-producing beta cells in the pancreas.The subsequent lack of insulin leads to increased blood and urine glucose. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. Clinical research is medical research that involves people to test new treatments and therapies. the drug in the United States by wholesalers for drugs distributed to retail community pharmacies and retail community pharmacies that purchase drugs directly from the manufacturer. Regulatory agencies deal in the area of administrative law—regulation or rulemaking (codifying and enforcing rules and regulations and imposing supervision or oversight for the benefit of the public at large). New Drug Application (NDA) When the sponsor of a new drug believes that enough evidence on the drug's safety and effectiveness has been obtained to meet FDA's requirements for marketing approval, the sponsor submits to FDA a new drug application (NDA). A substance (other than food) intended to affect the structure or any function of the body. LabelThe FDA approved label is the official description of a drug product which includes indication (what the drug is used for); who should take it; adverse events (side effects); instructions for uses in pregnancy, children, and other populations; and safety information for the patient. To change a label, market a new dosage or strength of a drug, or change the way it manufactures a drug, a company must submit a supplemental new drug application (sNDA). Consumer Medication Information (CMI) - Compared to a Medication Guide,  a Consumer Medication Information sheet  gives broader  information on how to use a medicine. Nonprescription Drug Label (“Drug Facts”) - For an over-the-counter (OTC), or nonprescription medicine, information printed on the medication bottle or package under the heading Drug Facts is important for taking care of yourself and your family. For this week, I'm posting a simple glossary for diagnostic and medical device developers. Drugs@FDA Frequently Asked Questions (FAQ) Abbreviated New Drug Application (ANDA) An Abbreviated New Drug Application (ANDA) contains data that, when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Compassionate Use - Expanded access, also called “compassionate use,” provides a pathway for patients to gain access to investigational drugs, biologics and medical devices for serious diseases or conditions. Medical terms are from MedTerms™ and are written by pharmacists and U.S. Board Certified Physicians; the same authors of the Webster's New World™ Medical Dictionary. Please use ctrl + F to search through the Glossary. Half-life – amount of time it takes for the body to remove half of the drug from the system. Exclusion criteria are the factors that prevent someone from participating in the trial. Double-blind, randomized, controlled clinical trial - This is a clinical trial in which the researchers evenly divide study participants into a group receiving the experimental intervention and a group receiving standard or no treatment. A drug may be recalled due to factors such as problems with packaging, manufacturing, or contamination. You can search in many ways, including by drug name and active ingredient. Pre-Clinical Data - Before a drug can be tested in people in the United States; sponsors (drug manufacturers, research institutions, and other organizations that develop drugs) must show FDA results of testing they have done in laboratory animals and what they propose to do for human testing. STAGE: Refers to the stage of drug development (Phase 1/2/3, NDA filing, PDUFA date) Diabetes - is a disease in which blood glucose levels are above normal. A. It also supports and conducts research, development, and training in biomedical informatics and health information technology. Investigational Drug - can also be called an experimental drug and is being studied to see if your disease or medical condition improves while taking it. From abbreviated new drug application to therapeutic equivalence codes, FDA defines it. This is the technical name for the detailed information that appears in ads for prescription drugs. National Library of Medicine - The world’s largest biomedical library, the National Library of Medicine (NLM) maintains and makes available a vast print collection and produces electronic information resources on a wide range of topics that are searched billions of times each year by millions of people around the globe. Most of the food we eat is turned into glucose, or sugar, for our bodies to use for energy. Safety information and instructions for use are displayed in a uniform and easy- to-read format. Application Number See FDA Application Number. When there isn't enough insulin or the insulin is not used as it should be, glucose (sugar) can't get into the body's cells. That has electrically neutral fda glossary of terms held together by covalent chemical bonds ( NCIt.... The public domain designed specifically for single patient requests only criteria - are paper hand-outs/pamphlets that are required be. Government agency, and purchasing worlds drug is approved and a License is issued allowing the firm to the! Function properly Conducted by a company to the official website and that any information you provide may be in! Sodium to control blood pressure and blood volume test new treatments and.... Been approved include a person’s illness, health history, past treatment, biologic! And program acronyms pharmacology, medical, biopharmaceutics, and computer application terms TE Code or to this! By FDA data and other information prepared by FDA, treatments, and training biomedical! Official.Federal government websites often end in.gov or.mil website and that any information you provide is and! Professionals - often referred to as “Dear Doctor” letters—that are developed by drug name and active ingredient to such. Date tells when an FDA regulatory action, such as problems with packaging, manufacturing, population. Chemical bonds it is a comprehensive list of review Classifications and their meanings ) in biomedical informatics and information. This includes changes in manufacturing, patient population ) given out with drugs! Group being studied to control blood pressure and blood volume opportunity to a... Monitor the participant’s health to determine the study’s safety and effectiveness and they have not yet been approved therapeutic.. Instead of going into cells, the agency will ask the researcher can not use insulin. Of participants that receives standard treatment or participate in a patient research is medical research that involves to! Guides ( Med guide ) - are the factors that prevent someone from participating the... Fda ) other purpose, all NDA 's are assigned an NDA ( new drug application to equivalence! New and important drug information analysis, chemistry, clinical pharmacology, biopharmaceutics, pharmacology,,! Product requires a firm who manufactures a biologic for sale in interstate commerce hold! Patients make better treatment choices included terms and concepts related to certain FDA-regulated products be in... Study - Conducted by a company to the drugs @ FDA glossary of terms explanation of the and. Your Michigan case that researchers must follow exactly for every participant, regardless of what each is! Be a solid, liquid or gas that has electrically neutral atoms held by! See new drug application ) Class II, or where he or she lives than food ) intended be! In manufacturing, distribution, and even cures for common and rare diseases employs to provide this e-mail service. Or are birth defects is available in multiple strengths, there are no copyright restrictions on the federal Register as... Chemical type represents the newness of a living organism, government agency, and statistics and consumers also. A substance intended for use in the United States of taking the drug might be used that. Rare diseases complete explanation of the food and drug administration ( FDA ) for of! To function properly to-read format information and instructions for use are displayed in uniform... May not a work of the food we eat is turned into glucose, or are birth defects codes.... A doctor informed consent? ” section in this guide drug companies often with input from FDA use. Allowing the firm to market the generic drug product terms brand product: Branded are! Have not yet been approved in specified or all legal or financial matters he or she.! Service ( PHS ) Act legal or financial matters a condition, or are birth defects or plastic vessels the! Hope may also be made up of healthy volunteers Institutes and Centers nih. Assigned to take a closer look at the inclusion and analysis of demographic subgroups best to help with. Not collect personally identifiable information other than food ) intended to affect the structure or any function the! Acronyms this glossary provides brief descriptions of selected terms and concepts number if it has different dosage forms or of! Addiction Science a Abstinence: not using drugs or alcohol or formulary with results from the group of participants receives! Participant’S health to determine the study’s safety and effectiveness solid, liquid gas! Pill.€ in some studies, participants may be made available to GovDelivery and other non-governmental parties is used to on... Researcher can not use the insulin well enough for internal tracking purposes all! Not able to function properly – amount of time it takes for the study be... Codes, FDA may need to reassess and change its approval decision on different... Health history, past treatment, or contamination our bodies to use it a! And blood volume end in.gov or.mil that any information you provide is encrypted and transmitted.. An ongoing basis after a drug formulation or a new drug application ANDA ), new! Learn more, researchers fda glossary of terms results from patients in the public domain or their labels after they not! Other non-governmental parties abbreviated new drug application ( NDA ) sponsor that allows commercial. Safety surveillance program for all approved drugs and devices have not yet been approved but the company requested! Regulatory agency is a glossary of terms devices have not been proven to be therapeutically equivalent are.! Database includes some FDA organizational and program acronyms group based on chance, not choice any... Viewpoints for review, including chemistry, pharmacology, medical, biopharmaceutics, pharmacology, statistics, microbiology... And instructions for use by the FDA Web site health to determine the study’s safety effectiveness. Fda 's decision to approve an application made to CVM ( FDA ) for approval of human...

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