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. The objective of FDA regulatory programs is to ensure compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). Information about the potential benefits and risks of taking the drug. Diabetes - is a disease in which blood glucose levels are above normal. Glossary of acronyms and abbreviations. NDA = New Drug Application. Form FDA 3926 - Used by physicians when submitting requests for expanded access to investigational drugs, including emergency requests. An independent regulatory agency is a regulatory agency that is independent from other branches or arms of the government. Drug Product The finished dosage form that contains a drug substance, generally, but not necessarily in association with other active or inactive ingredients. 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. This definition applies to covered outpatient drugs of a manufacturer ... 340B Glossary of Terms . (List of Review Classifications and their meanings). A drug can have more than one application number if it has different dosage forms or routes of administration. 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. 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. Other studies are termed exploratory studies. There are no copyright restrictions on the Federal Register; as a work of the U.S. government, it is in the public domain. A drug may be recalled due to factors such as problems with packaging, manufacturing, or contamination. Biologic License Application (BLA)Biological products are approved for marketing under the provisions of the Public Health Service (PHS) Act. The emphasis is on scientific, regulatory, government agency, and computer application terms. The .gov means itâs official.Federal government websites often end in .gov or .mil. Supplement Type Companies are allowed to make changes to drugs or their labels after they have been approved. 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. Other words to describe clinical research are âclinical trial,â âprotocol,â âstudy,â and âexperiment.â. Protocol - A study done to answer a question. CMI sheets are not available on the FDA Web site. Drug Crime Glossary of Terms Below is a glossary of drug crime terms that may be relevant to your Michigan case. 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. These are proteins derived from living material (such as cells or tissues) used to treat or cure disease. 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. MedWatch - MedWatch is FDAâs safety information and adverse event reporting program. What Are the Different Types of Clinical Research? Marijuana. It also supports and conducts research, development, and training in biomedical informatics and health information technology. Abbreviated New Animal Drug Application (ANADA) An application made to CVM (FDA) for approval of a generic animal drug. Half-life – amount of time it takes for the body to remove half of the drug from the system. 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. Placebo effect - Sometimes people taking a study medication receive benefits that are not from the chemicals in the medicine. Too much glucose in your blood can damage your body over time. When FDA believes that a drugâs benefits no longer outweigh its risks, the agency will ask the manufacturer to withdraw the drug. This and other terminology used by the FDA are updated and made available for download via the NCI File Transfer Protocol (FTP). Patient Network News - This bi-weekly newsletter provided by the Office of Health and Constituent Affairs isÂ 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. Each sNDA is assigned a number which is usually, but not always, sequential, starting with 001. A review is divided into sections on medical analysis, chemistry, clinical pharmacology, biopharmaceutics, pharmacology, statistics, and microbiology. 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Approval Letter An official communication from FDA to a new drug application (NDA) sponsor that allows the commercial marketing of the product. Comparison - To learn more, researchers compare results from patients in the experimental groups with results from patients in the control groups.  Citations from the Federal Register are [volume] FR [page number] ([date]), e.g., 65 FR 741 (Jan. 6, 2000). These factors may include a personâs illness, health history, past treatment, age, sex, or where he or she lives. Approval History The approval history is a chronological list of all FDA actions involving one drug product having a particular FDA Application number (NDA). Information you provide may be made available to GovDelivery and other non-governmental parties. Healthy volunteer - In a clinical study, a person who does not have the disorder or disease being studied. This is the technical name for the detailed information that appears in ads for prescription drugs. A. AADA – Abbreviated antibiotic drug application. 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. An official website of the United States government, : Clinical Trial. Drug Recall - A drug recall is an action taken by a firm to remove a product from the market that FDA considers to be in violation of the law. 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. For example, an experiment that is done in vivo is done in the body of a living organism. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). 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. If a drug product is available in multiple strengths, there are multiple product numbers. The Act requires a firm who manufactures a biologic for sale in interstate commerce to hold a license for the product. You have the same chance to be placed in any of the test groups. A substance (other than food) intended to affect the structure or any function of the body. Over-the-Counter Drugs (OTC)FDA defines OTC drugs as safe and effective for use by the general public without a doctor's prescription. Type 1 Diabetes - Diabetes mellitus typeÂ 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. Therefore, they may be effective in the treatment of a condition, or they may not. Drug Product Recalls - FDA provides information on drug products that have been recalled due to manufacturing problems and/or safety concerns.Â In addition to information released to the public by a manufacturer using the normal media channels. Product Number A product number is assigned to each drug product associated with an NDA (New Drug Application). Drug Withdrawal - In rare cases, FDA may need to reassess and change its approval decision on a drug. 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. Clinical research is medical research that involves people to test new treatments and therapies. Prediabetes - means the amount of glucose, also called sugar, in your blood is higher than normal but not high enough to be called diabetes. 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. 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). 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. National Library of Medicine - The worldâs 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. ABHI – Association of British Healthcare Industries. FDA Action Date The action date tells when an FDA regulatory action, such as an original or supplemental approval, took place. The application must contain data from specific technical viewpoints for review, including chemistry, pharmacology, medical, biopharmaceutics, and statistics. ABPI – Association of the British Pharmaceutical Industry. Marketing Status Marketing status indicates how a drug product is sold in the United States. In vitro is the opposite of in vivo. Biological ProductBiological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. More than almost 25,000 FDA terms and codes are stored in NCI Thesaurus (NCIt). Sodium is also needed for your muscles and nerves to work properly. 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). An application by a company to the FDA to market a drug. Post-Market Surveillance - is the process by which a drugâs safety is monitored on an ongoing basis after a drug is approved by FDA. It belongs … Therapeutic Equivalence (TE)Drug products classified as therapeutically equivalent can be substituted with the full expectation that the substituted product will produce the same clinical effect and safety profile as the prescribed product. Over-the-counter drugs are not assigned TE codes. (list of Chemical Types and their meanings). 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. Investigational drugs and devices have not yet been approved by the FDA and they have not been proven to be safe and effective. 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. Glossary of Medical Device Industry Terms. Experiment - A study done to answer a question. Glossary of Terms Medical Device. 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. Medication Guides (Med Guide) - are paper hand-outs/pamphlets that are required to be given to patients with certain medications by the pharmacist. This condition is also referred to as potentiation. The control group may also be made up of healthy volunteers. Application Number See FDA Application Number. But either their pancreas does not make enough insulin or the body cannot use the insulin well enough. For more detailed information, see the âWhat is informed consent?â section in this guide. 123 ... with the Food and Drug Administration (FDA). Below is a glossary of terms commonly used by players in the drug research, regulation, manufacturing, distribution, and purchasing worlds. The letters educate healthcare professionals about new and important drug information. 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. Brand Name DrugA brand name drug is a drug marketed under a proprietary, trademark-protected name. STAGE: Refers to the stage of drug development (Phase 1/2/3, NDA filing, PDUFA date) [ICH Q6B] Measurable terms under which a test result will be considered acceptable. 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. 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. Durable power of attorney - The authority to act for another person in specified or all legal or financial matters. It is a comprehensive analysis of clinical trial data and other information prepared by FDA drug application reviewers. FDA will not use or share your e-mail address for any other purpose. Most of the food we eat is turned into glucose, or sugar, for our bodies to use for energy. Synergy – when two or more drugs are taken together; the combined action increases the normal effect of each drug. 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. The FDA bases evaluations of substitutability, or "therapeutic equivalence," of generic drugs on scientific evaluations. New Drug Approval Process - After the animal testing stage, FDA decides whether it is reasonably safe for the company to move forward with clinical trialsâstudies that evaluate the safety and effectiveness of a drug in healthy people and in patients. 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. Exclusion criteria are the factors that prevent someone from participating in the trial. Please use ctrl + F to search through the Glossary. If the information provided meets FDA requirements, the application is approved and a license is issued allowing the firm to market the product. A substance intended for use as a component of a medicine but not a device or a component, part or accessory of a device. ACTD – ASEAN common technical dossier. Glossary of Terms Learn “FDA-Speak” The Food and Drug Administration has its own set of unique terminology, definitions, and regulatory requirements. For this week, I'm posting a simple glossary for diagnostic and medical device developers. Brief Summary. Adverse events can range from mild to severe. A comprehensive list of specific routes of administration appears in the CDER Data Standards Manual. 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. 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. Drug products evaluated as "therapeutically equivalent" can be expected to have equal effect and no difference when substituted for the brand name product. The Drug Facts tell you what a medicine is supposed to do, who should or should not take it, and how to use it. From abbreviated new drug application to therapeutic equivalence codes, FDA defines it. ... 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. 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. 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.”. Instead, a generic applicant must scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the innovator drug). A substance recognized by an official pharmacopoeia or formulary. Recalls are classified as Class I, Class II, or Class III. Outpatient - A person who receives treatment or participates in a study but is not hospitalized overnight. CompanyThe company (also called applicant or sponsor) submits an application to FDA for approval to market a drug product in the United States. Those related terms are located sequentially to assist the user in finding all defined terms in these domains, e.g., functional testing is defined under testing, functional. 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. 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. Usually a surveyed pharmacy drug acquisition cost. 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. 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. 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 Pharmaceutical EquivalentsFDA considers drug products to be pharmaceutical equivalents if they meet these three criteria: Pharmaceutically equivalent drug products may differ in characteristics such as. Salt contains sodium. 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. Expand All | Collapse All. sNDA = Supplementary New Drug Application (i.e. Placebo - An inactive pill. Inclusion/exclusion criteria - are the factors that allow someone to participate in a clinical trial. 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.”. In general, the term "drugs" includes therapeutic biological products. AAC: Actual Acquisition Cost. 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. Early Communication about an Ongoing Safety Review - This type of communication is part of FDAâs effort to communicate early with the public when the agency is still evaluating data and has not reached a conclusion. The GovDelivery service FDA employs to provide this e-mail subscription service is not a government entity. Composed of 27 Institutes and Centers, NIH provides leadership and financial support to researchers in every state and throughout the world. By law, a generic drug product must contain the identical amounts of the same active ingredient(s) as the brand name product. Sodium - an element that the body needs to work properly. It is a daily (except federal holidays) publication. Other words to describe an experiment are âresearch,â âstudy,â and âprotocol.â. This form is designed specifically for single patient requests only. Investigational drugs and devices have not yet been approved by the FDA and they have not been proven to be safe and effective. 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. Type 2 Diabetes - Type 2 diabetes, once called non-insulin-dependent diabetes, is the most common form of diabetes, affecting 90% to 95% of the 26 million Americans with diabetes. When glucose builds up in the blood instead of going into cells, the body's cells are not able to function properly. 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. A tentative approval does not allow the applicant to market the generic drug product. The researcher cannot use a different method for you. Members of the research team regularly monitor the participantâs health to determine the studyâs safety and effectiveness. 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. The supplement type refers to the kind of change that was approved by FDA. Welcome to the Drugs@FDA glossary of terms. Standardized procedures - These are study rules that researchers must follow exactly for every participant, regardless of what each participant is used to. 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. And adverse Event Reporting system ( FAERS ) - are the factors that someone. Changes in manufacturing, patient population, and training in biomedical informatics and health technology... Sharing sensitive information, see the âWhat is informed consent? â section in this guide application ANDA ) abbreviated... Market the generic drug product is sold in the United States who receives treatment or participate in test... 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