Code of Federal Regulations Title 21 Part 56. 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. ... Food and Drug Administration. National Institutes of Health (NIH) - Part of the U.S. Department of Health and Human Services, NIH is the primary Federal agency for conducting and supporting medical research. 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 Experimental group - The group of participants in a study that receive the experimental or study intervention (such as medication or psychotherapy). Commonly Used Terms in Addiction Science A Abstinence: Not using drugs or alcohol. 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. The tentative approval letter details the circumstances associated with the tentative approval. A conclusion that a drug should no longer be marketed is based on the nature and frequency of the adverse events and how the drugâs benefit and risk balance compares with treatment alternatives. These are proteins derived from living material (such as cells or tissues) used to treat or cure disease. Glossary of acronyms and abbreviations. In general, the term "drugs" includes therapeutic biological products. An official website of the United States government, : Cardiovascular disease - also called heart disease is a class of diseases that involve the heart, the blood vessels (arteries, capillaries, and veins) or both. A review is divided into sections on medical analysis, chemistry, clinical pharmacology, biopharmaceutics, pharmacology, statistics, and microbiology. Those products which the FDA does not deem to be therapeutically equivalent are ". Reproducibility: The ability of a test device to produce the same value during repeated measurements in various laboratories which are participating in a collaborative study. Instead, a generic applicant must scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the innovator drug). Usually a surveyed pharmacy drug acquisition cost. Other studies are termed exploratory studies. Adverse events can range from mild to severe. It provides important and timely medical product information to healthcare professionals, including information on prescription and over- the-counter drugs, biologics, medical devices, and special nutritional products. FDA shares information in the interest of informing doctors and patients about the issues that are under review and when FDA experts anticipate completing their review. If the information provided meets FDA requirements, the application is approved and a license is issued allowing the firm to market the product. 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. 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. 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. Outpatient - A person who receives treatment or participates in a study but is not hospitalized overnight. ABPI – Association of the British Pharmaceutical Industry. the drug has already been approved but the company has requested to use it on a different patient population). The FDA bases evaluations of substitutability, or "therapeutic equivalence," of generic drugs on scientific evaluations. 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. In Drugs@FDA, you can find the NDA number under the column named "FDA Application.". Clinical Trial. For internal tracking purposes, all NDA's are assigned an NDA number. RouteA route of administration is a way of administering a drug to a site in a patient. 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. The emphasis is on scientific, regulatory, government agency, and computer application terms. When FDA believes that a drugâs benefits no longer outweigh its risks, the agency will ask the manufacturer to withdraw the drug. Glossary of Medical Device Industry Terms. Clinical Trials: What Patients Need to Know, Recalls, Market Withdrawals and Safety Alerts, Clinical Trials: What Patients Need to Know, What Patients Need to Know About Institutional Review Boards, Clinical Research Versus Medical Treatment. 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). Scientists do research when theyâre not sure what will work best to help people with an illness. 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. The primary purpose of such review is to assure the protection of the rights and welfare of the human subjects. CDRH - (Center for Devices and Radiological Health) assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. Synergy – when two or more drugs are taken together; the combined action increases the normal effect of each drug. Experiment - A study done to answer a question. The letters educate healthcare professionals about new and important drug information. Neither group knows how it has been assigned. Nonprescription Drug Label (âDrug Factsâ) - 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. Therefore, they may be effective in the treatment of a condition, or they may not. For example, an experiment that is done in vivo is done in the body of a living organism. "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. Regulatory Agency - is a public authority or government agency responsible for exercising autonomous authority over some area of human activity in a regulatory or supervisory capacity. 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. More than almost 25,000 FDA terms and codes are stored in NCI Thesaurus (NCIt). Strength The strength of a drug product tells how much of the active ingredient is present in each dosage. 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. 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. 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). Compliance Action Types. In vitro is the opposite of in vivo. Class I recalls are the most serious and involve situations where there is a reasonable probability that the use of or exposure to a volatile product, will cause serious adverse health consequences or death. It is not intended to be a comprehensive list of relevant terms or to provide a complete explanation of the included terms and concepts. Form FDA 3926 - Used by physicians when submitting requests for expanded access to investigational drugs, including emergency requests. When glucose builds up in the blood instead of going into cells, the body's cells are not able to function properly. A substance intended for use as a component of a medicine but not a device or a component, part or accessory of a device. 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. Reg., is the official journal of the federal government of the United States that contains most routine publications and public notices of government agencies. Results from healthy controls are compared to results from the group being studied. This definition applies to covered outpatient drugs of a manufacturer ... 340B Glossary of Terms . Expanded Access - also called âcompassionate use,â provides a pathway for patients to gain access to investigational drugs, biologics and medical devices for serious diseases or conditions. Each sNDA is assigned a number which is usually, but not always, sequential, starting with 001. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public. 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). Before sharing sensitive information, make sure you're on a federal government site. Double-blind research design helps minimize the placebo effect. 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. Inclusion/exclusion criteria - are the factors that allow someone to participate in a clinical trial. CompanyThe company (also called applicant or sponsor) submits an application to FDA for approval to market a drug product in the United States. This report provided an important opportunity to take a closer look at the inclusion and analysis of demographic subgroups. Diabetes - is a disease in which blood glucose levels are above normal. Glucose is a form of sugar your body uses for energy. Research - A study done to answer a question. Glossary of Terms. 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. A. AADA – Abbreviated antibiotic drug application. Please use ctrl + F to search through the Glossary. 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. ), 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. National Cancer Institute - (NCI) is part of the National Institutes of Health (NIH), which is one of 11 agencies that compose the Department of Health and Human Services (HHS). This is called insulin resistance. 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