Labels are often found inside drug product packaging. 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. An independent regulatory agency is a regulatory agency that is independent from other branches or arms of the government. 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. Other studies are termed exploratory studies. 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. Exclusion criteria are the factors that prevent someone from participating in the trial. Drug Withdrawal - In rare cases, FDA may need to reassess and change its approval decision on a drug. Members of the research team regularly monitor the participant’s health to determine the study’s safety and effectiveness. FDA will not use or share your e-mail address for any other purpose. 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. Glossary of Terms Learn “FDA-Speak” The Food and Drug Administration has its own set of unique terminology, definitions, and regulatory requirements. Researchers compare results from the control group with results from the experimental group to find and learn from any differences. 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. Glossary of acronyms and abbreviations. More than almost 25,000 FDA terms and codes are stored in NCI Thesaurus (NCIt). Control group - The group of participants that receives standard treatment or a placebo. 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. 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. 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. 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. 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”. 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. The database includes some FDA organizational and program acronyms. ABHI – Association of British Healthcare Industries. 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 official website of the United States government, : The Act requires a firm who manufactures a biologic for sale in interstate commerce to hold a license for the product. Experiment - A study done to answer a question. DailyMed - Developed with the National Library of Medicine, DailyMed is a Web site that gives physicians and patients electronic access to FDA-approved drug labels. 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. 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. Standardized procedures - These are study rules that researchers must follow exactly for every participant, regardless of what each participant is used to. It belongs … A review is divided into sections on medical analysis, chemistry, clinical pharmacology, biopharmaceutics, pharmacology, statistics, and microbiology. Clinical Research. 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. Supplement Type Companies are allowed to make changes to drugs or their labels after they have been approved. 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. 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. Placebo - An inactive pill. Glossary of Terms Medical Device. Scientists do research when they’re not sure what will work best to help people with an illness. Standard treatment - The treatment that medical professionals consider at the time of the study to be the most prevalent and best available treatment. the drug has already been approved but the company has requested to use it on a different patient population). The site is secure. ), 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. 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. ABPI – Association of the British Pharmaceutical Industry. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public. Federal Register - abbreviated FR or sometimes Fed. Molecular compound - may be a solid, liquid or gas that has electrically neutral atoms held together by covalent chemical bonds. ACTD – ASEAN common technical dossier. Consumer Medication Information (CMI) - Compared to a Medication Guide,  a Consumer Medication Information sheet  gives broader  information on how to use a medicine. A. 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). Strength The strength of a drug product tells how much of the active ingredient is present in each dosage. In general, the term "drugs" includes therapeutic biological products. 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. Supplement Number A supplement number is associated with an existing FDA New Drug Application (NDA) number. STAGE: Refers to the stage of drug development (Phase 1/2/3, NDA filing, PDUFA date) In vivo - In the living organism. Protocol - A study done to answer a question. This definition applies to covered outpatient drugs of a manufacturer ... 340B Glossary of Terms . In vivo is the opposite of in vitro. 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”. 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. A researcher’s hope may also sway a participant’s response. 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. Scientists are trying to prove in clinical trials: How the drug might be used in that disease. Usually a surveyed pharmacy drug acquisition cost. 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. Before sharing sensitive information, make sure you're on a federal government site. Some drug products have more than one TE Code. 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). Other words to describe an experiment are “research,” “study,” and “protocol.”. 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. Half-life – amount of time it takes for the body to remove half of the drug from the system. Participants are assigned to a group based on chance, not choice. A comprehensive list of specific routes of administration appears in the CDER Data Standards Manual. 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. FDA delays final approval of the generic drug product until all patent or exclusivity issues have been resolved. (List of Review Classifications and their meanings). Information about the potential benefits and risks of taking the drug. There are literally hundreds of slang terms or street names for marijuana or cannabis, … Double-blind research design helps minimize the placebo effect. Sample TE codes: AA, AB, BC (More on TE Codes). Synergy – when two or more drugs are taken together; the combined action increases the normal effect of each drug. Form FDA 3926 - Used by physicians when submitting requests for expanded access to investigational drugs, including emergency requests. 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. This report provided an important opportunity to take a closer look at the inclusion and analysis of demographic subgroups. Results from the study will usually be presented in terms of trends or overall findings and will not mention any specific participants. 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. CMI sheets are not developed or regulated by FDA. 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. Diabetes - is a disease in which blood glucose levels are above normal. 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. CompanyThe company (also called applicant or sponsor) submits an application to FDA for approval to market a drug product in the United States. These factors may include a person’s illness, health history, past treatment, age, sex, or where he or she lives. 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. 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. Too much glucose in your blood can damage your body over time. The .gov means it’s official.Federal government websites often end in .gov or .mil. Experimental group - The group of participants in a study that receive the experimental or study intervention (such as medication or psychotherapy). The control group may also be made up of healthy volunteers. 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.”. Product Number A product number is assigned to each drug product associated with an NDA (New Drug Application). 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. Unlike people with type 1 diabetes, the bodies of people with type 2 diabetes make insulin. 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. Over-the-Counter Drugs (OTC)FDA defines OTC drugs as safe and effective for use by the general public without a doctor's prescription. This form is designed specifically for single patient requests only. Each sNDA is assigned a number which is usually, but not always, sequential, starting with 001. 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. Durable power of attorney - The authority to act for another person in specified or all legal or financial matters. Results from healthy controls are compared to results from the group being studied. 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. Expand All | Collapse All. This condition is also referred to as potentiation. If a drug product is available in multiple strengths, there are multiple product numbers. What Are the Different Types of Clinical Research? Other words to describe a study are “clinical trial,” “protocol,” “experiment,” and “research.”. Glossary of clinical trial terms. 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. What’s the meaning of this? The GovDelivery service FDA employs to provide this e-mail subscription service is not a government entity. Therefore, they may be effective in the treatment of a condition, or they may not. 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. 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. In vitro - In glass, as in a test tube. Adverse events can range from mild to severe. For this week, I'm posting a simple glossary for diagnostic and medical device developers. From abbreviated new drug application to therapeutic equivalence codes, FDA defines it. The researcher cannot use a different method for you. "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. NIH scientists investigate ways to prevent disease as well as the causes, treatments, and even cures for common and rare diseases. For example, an experiment that is done in vivo is done in the body of a living organism. Serious adverse events are those that can cause disability, are life-threatening, result in hospitalization or death, or are birth defects. 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. If the NDA is approved, the product may be marketed in the United States. Sodium - an element that the body needs to work properly. Clinical research is medical research that involves people to test new treatments and therapies. 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). If the information provided meets FDA requirements, the application is approved and a license is issued allowing the firm to market the product. This includes changes in manufacturing, patient population, and formulation. The letters educate healthcare professionals about new and important drug information. 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