fda glossary of terms

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07.01.21

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. 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. Serious adverse events are those that can cause disability, are life-threatening, result in hospitalization or death, or are birth defects. ofloxacin listen (oh-FLOK-suh-sin) An antibiotic drug used to treat infection. If you have prediabetes, also called impaired fasting glucose (IFG) or impaired glucose tolerance (IGT), you are more likely to develop type 2 diabetes, heart disease, and stroke. Brief Summary. ... Food and Drug Administration. Scientists do research when they’re not sure what will work best to help people with an illness. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public. By law, a generic drug product must contain the identical amounts of the same active ingredient(s) as the brand name product. Protocol - A study done to answer a question. Numerical limits, ranges, or other suitable measures for acceptance of the results of analytical procedures which the drug substance or drug product or materials at other stages of their manufacture should meet. Other words to describe a protocol are “research,” “study,” and “experiment.” “Protocol” also refers to the plan that details what researchers will do during the study. The Federal Register is compiled by the Office of the Federal Register (within the National Archives and Records Administration) and is printed by the Government Printing Office. Recalls are classified as Class I, Class II, or Class III. When FDA believes that a drug’s benefits no longer outweigh its risks, the agency will ask the manufacturer to withdraw the drug. Glossary of Terms Medical Device. This includes changes in manufacturing, patient population, and formulation. Supplement Type Companies are allowed to make changes to drugs or their labels after they have been approved. Before sharing sensitive information, make sure you're on a federal government site. You have the same chance to be placed in any of the test groups. CMI sheets are not developed or regulated by FDA. If you have symptoms of fever, cough or difficulty breathing, have traveled to areas impacted by the Coronavirus (2019-nCoV) within the past 14 days, and/or have been in close contact with someone who has traveled outside the US or been exposed to the Coronavirus please call your primary clinic before coming in for your appointment. It is important to remember that the drug/biologic/medical device may have unexpected serious side effects and that patients need to consider all the possible risks when seeking access to an investigational medical product. This is the technical name for the detailed information that appears in ads for prescription drugs. 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. Medication Guides communicate risk information that is specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events. 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.”. 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. Code of Federal Regulations Title 21 Part 56. Please use ctrl + F to search through the Glossary. The NCI coordinates the National Cancer Program, which conducts and supports research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Unlike people with type 1 diabetes, the bodies of people with type 2 diabetes make insulin. A. One drug can have more than one application number if it has different dosage forms or routes of administration. Durable power of attorney - The authority to act for another person in specified or all legal or financial matters. The database includes some FDA organizational and program acronyms. Investigational drugs and devices have not yet been approved by the FDA and they have not been proven to be safe and effective. Drug products are considered to be therapeutically equivalent only if they meet these criteria: Therapeutic Equivalence (TE) Codes The coding system for therapeutic equivalence evaluations allows users to determine whether FDA has evaluated a particular approved product as therapeutically equivalent to other pharmaceutically equivalent products (first letter) and to provide additional information on the basis of FDA's evaluations (second letter). Also known as a "Premarket Notification" a 510(k) notification allows the FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Review ClassificationThe NDA and BLA classification system provides a way of describing drug applications upon initial receipt and throughout the review process and prioritizing their review. 123 ... with the Food and Drug Administration (FDA). Sample TE codes: AA, AB, BC (More on TE Codes). Research - A study done to answer a question. Glossary of clinical trial terms. The application must contain data from specific technical viewpoints for review, including chemistry, pharmacology, medical, biopharmaceutics, and statistics. 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. Outpatient - A person who receives treatment or participates in a study but is not hospitalized overnight. 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. [ICH Q6B] Measurable terms under which a test result will be considered acceptable. 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. Glossary of Terms. The emphasis is on scientific, regulatory, government agency, and computer application terms. The GovDelivery service FDA employs to provide this e-mail subscription service is not a government entity. NDA = New Drug Application. 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. 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. Neither group knows how it has been assigned. [Main Principles for Pharmaceutical Products, WHO] Abbreviated New Animal Drug Application (ANADA) An application made to CVM (FDA) for approval of a generic animal drug. FDA does not collect personally identifiable information other than your e-mail address which is needed in order to provide the service. Comparison - To learn more, researchers compare results from patients in the experimental groups with results from patients in the control groups. If the information provided meets FDA requirements, the application is approved and a license is issued allowing the firm to market the product. Before approving a generic drug product, FDA requires many rigorous tests and procedures to assure that the generic drug can be substituted for the brand name drug. This is called insulin resistance. Biologic License Application (BLA)Biological products are approved for marketing under the provisions of the Public Health Service (PHS) Act. Reg., is the official journal of the federal government of the United States that contains most routine publications and public notices of government agencies. An official website of the United States government, : Placebo - An inactive pill. Welcome to the Drugs@FDA glossary of terms. Over-the-counter drugs are not assigned TE codes. You can search in many ways, including by drug name and active ingredient. ... 483 – An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. 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. FDA Application Number This number, also known as the NDA (New Drug Application) number, is assigned by FDA staff to each application for approval to market a new drug in the United States. In vitro is the opposite of in vivo. A. AADA – Abbreviated antibiotic drug application. 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 intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Sodium - an element that the body needs to work properly. Scientists are trying to prove in clinical trials: How the drug might be used in that disease. FDA delays final approval of the generic drug product until all patent or exclusivity issues have been resolved. Dosage Form A dosage form is the physical form in which a drug is produced and dispensed, such as a tablet, a capsule, or an injectable. 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. Unless you work for the FDA or the European Commission, it can be a challenge to keep track of all the acronyms and terms involved in regulatory issues and agencies. A comprehensive list of specific routes of administration appears in the CDER Data Standards Manual. Drug Crime Glossary of Terms Below is a glossary of drug crime terms that may be relevant to your Michigan case. Glossary; Glossary. 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. ), excipients (including colors, flavors, preservatives), designates a brand name drug or a generic drug to be the, assigns therapeutic equivalence codes based on data that a drug sponsor submits in an, FDA assigns therapeutic equivalence codes to, a drug company's approved application contains adequate scientific evidence establishing through, those active ingredients or dosage forms for which no. Approval History The approval history is a chronological list of all FDA actions involving one drug product having a particular FDA Application number (NDA). For this week, I'm posting a simple glossary for diagnostic and medical device developers. Brand Name DrugA brand name drug is a drug marketed under a proprietary, trademark-protected name. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). FDA will not use or share your e-mail address for any other purpose. Glucose is a form of sugar your body uses for energy. 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. Each sNDA is assigned a number which is usually, but not always, sequential, starting with 001. the drug has already been approved but the company has requested to use it on a different patient population). 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. Members of the research team regularly monitor the participant’s health to determine the study’s safety and effectiveness. Experimental group - The group of participants in a study that receive the experimental or study intervention (such as medication or psychotherapy). Composed of 27 Institutes and Centers, NIH provides leadership and financial support to researchers in every state and throughout the world. (List of Review Classifications and their meanings). FDA Action Date The action date tells when an FDA regulatory action, such as an original or supplemental approval, took place. Clinical Outcome Assessment (COA): Glossary of Terms Adequate and well-controlled (A&WC) studies — These are studies used to support drug marketing authorization and intended to provide substantial evidence of effectiveness required by law to support a conclusion that a drug is effective (see 21 CFR 314.126). FDA Glossary list of computer and software terms with definitions from IEEE, ANSI, ISO, NIST, NBS, and various other sources A PRAXIS LIFE SCIENCES knowledge center & resource +1 (847) 295-7160 Molecular compound - may be a solid, liquid or gas that has electrically neutral atoms held together by covalent chemical bonds. Commonly Used Terms in Addiction Science A Abstinence: Not using drugs or alcohol. "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. Cardiovascular disease - also called heart disease is a class of diseases that involve the heart, the blood vessels (arteries, capillaries, and veins) or both. New Molecular Entity (NME) An NME is an active ingredient that contains no active moiety that has been previously approved by the Agency in an application submitted under section 505 of the Federal Food, Drug, and Cosmetic Act, or has been previously marketed as a drug in the United States. 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. Federal Register - abbreviated FR or sometimes Fed. ABPI – Association of the British Pharmaceutical Industry. It is a comprehensive analysis of clinical trial data and other information prepared by FDA drug application reviewers. Exclusion criteria are the factors that prevent someone from participating in the trial. Privacy Policy - We have a strict privacy policy. 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. Glossary of acronyms and abbreviations. The RxList drug medical dictionary contains definitions and explanations of many medical terms including prescription medication abbreviations. RLD (Reference Listed Drug) A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. 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. Healthcare professionals and consumers can also report serious problems they suspect are related to certain FDA-regulated products. Too much glucose in your blood can damage your body over time. The drug company submits the results of such studies to FDA for review. These factors may include a person’s illness, health history, past treatment, age, sex, or where he or she lives. Other words to describe an experiment are “research,” “study,” and “protocol.”. 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. Usually a surveyed pharmacy drug acquisition cost. The tentative approval letter details the circumstances associated with the tentative approval. 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. Therapeutic Biological ProductA therapeutic biological product is a protein derived from living material (such as cells or tissues) used to treat or cure disease. CompanyThe company (also called applicant or sponsor) submits an application to FDA for approval to market a drug product in the United States. (list of Chemical Types and their meanings). 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. From abbreviated new drug application to therapeutic equivalence codes, FDA defines it. More information on FAERS. 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). Investigational drugs and devices have not yet been approved by the FDA and they have not been proven to be safe and effective. They are issued when FDA has information that would help doctors and patients make better treatment choices. Clinical research is medical research that involves people to test new treatments and therapies. Sponsors - Clinical trials are sponsored or funded by various organizations or individuals, including physicians, foundations, medical institutions, voluntary groups, and pharmaceutical companies, as well as Federal agencies such as NIH, FDA, the Department of Defense, and the Department of Veterans Affairs. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. sNDA = Supplementary New Drug Application (i.e. From abbreviated new drug application to therapeutic equivalence codes, FDA defines it. Product Number A product number is assigned to each drug product associated with an NDA (New Drug Application). 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. A substance recognized by an official pharmacopoeia or formulary. RouteA route of administration is a way of administering a drug to a site in a patient. Prescription Drug Product A prescription drug product requires a doctor's authorization to purchase. 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 … Clinical Trial. If a drug product is available in multiple strengths, there are multiple product numbers. This and other terminology used by the FDA are updated and made available for download via the NCI File Transfer Protocol (FTP). A substance intended for use as a component of a medicine but not a device or a component, part or accessory of a device. When glucose builds up in the blood instead of going into cells, the body's cells are not able to function properly. Below is a glossary of terms commonly used by players in the drug research, regulation, manufacturing, distribution, and purchasing worlds. FDA Adverse Event Reporting System (FAERS) - is a computerized database containing reports of adverse events. Early Communication about an Ongoing Safety Review - This type of communication is part of FDA’s effort to communicate early with the public when the agency is still evaluating data and has not reached a conclusion. Compliance Action Types. More than almost 25,000 FDA terms and codes are stored in NCI Thesaurus (NCIt). 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. Therefore, they may be effective in the treatment of a condition, or they may not. Discontinued Drug Product Products listed in Drugs@FDA as "discontinued" are approved products that have never been marketed, have been discontinued from marketing, are for military use, are for export only, or have had their approvals withdrawn for reasons other than safety or efficacy after being discontinued from marketing. In most cases, patients who seek compassionate use must have exhausted all approved therapies for their condition, and be unable toenroll in a clinical trial. Drug Product Terms Brand product: Branded products are not generic drugs or products. 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”. 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. 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. Labels are often found inside drug product packaging. 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. An application by a company to the FDA to market a drug. 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. Standardized procedures - These are study rules that researchers must follow exactly for every participant, regardless of what each participant is used to. Salt contains sodium. 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. For example, Chemical Type 1 is assigned to an active ingredient that has never before been marketed in the United States in any form. The body uses sodium to control blood pressure and blood volume. Drugs@FDA - Drugs@FDA is a resource allows  you  to  search for information about  FDA approved brand  name  and  generic  drugs  and therapeutic  biological products . Approval Letter An official communication from FDA to a new drug application (NDA) sponsor that allows the commercial marketing of the product. Synergy – when two or more drugs are taken together; the combined action increases the normal effect of each drug. 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. Information you provide may be made available to GovDelivery and other non-governmental parties. Double-blind research design helps minimize the placebo effect. This is sometimes called a “sugar pill.” In some studies, participants may be assigned to take a placebo rather than the study medication. 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. 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. This condition is also referred to as potentiation. Drug products evaluated as "therapeutically equivalent" can be expected to have equal effect and no difference when substituted for the brand name product. 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