Below is a glossary of terms commonly used by players in the drug research, regulation, manufacturing, distribution, and purchasing worlds. Welcome to the Drugs@FDA glossary of terms. By law, a generic drug product must contain the identical amounts of the same active ingredient(s) as the brand name product. Please use ctrl + F to search through the Glossary. You have the same chance to be placed in any of the test groups. Over-the-Counter Drugs (OTC)FDA defines OTC drugs as safe and effective for use by the general public without a doctor's prescription. A. AADA – Abbreviated antibiotic drug application. A substance intended for use as a component of a medicine but not a device or a component, part or accessory of a device. Clinical Research. Glossary of Medical Device Industry Terms. 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. ReviewA review is the basis of FDA's decision to approve an application. 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. Therapeutic Biological ProductA therapeutic biological product is a protein derived from living material (such as cells or tissues) used to treat or cure disease. Welcome to the Drugs@FDA glossary of terms. Each sNDA is assigned a number which is usually, but not always, sequential, starting with 001. CompanyThe company (also called applicant or sponsor) submits an application to FDA for approval to market a drug product in the United States. 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. 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. 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. Usually a surveyed pharmacy drug acquisition cost. For this week, I'm posting a simple glossary for diagnostic and medical device developers. Glossary of Terms. The researcher cannot use a different method for you. [ICH Q6B] Measurable terms under which a test result will be considered acceptable. They are issued when FDA has information that would help doctors and patients make better treatment choices. Unlike people with type 1 diabetes, the bodies of people with type 2 diabetes make insulin. The site is secure. 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. Inpatient - A person who is hospitalized for at least one night to receive treatment or participate in a study. Glossary of Terms Medical Device. Form FDA 3926 - Used by physicians when submitting requests for expanded access to investigational drugs, including emergency requests. Listed here are examples of some common terms for various commodity areas and their plain language definitions. 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 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. 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. Double-blind research design - A study in which neither the participant nor the researcher knows whether the participant is in the treatment or control group. Compliance Action Types. FDA Adverse Event Reporting System (FAERS) - is a computerized database containing reports of adverse events. 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. A review is divided into sections on medical analysis, chemistry, clinical pharmacology, biopharmaceutics, pharmacology, statistics, and microbiology. [Main Principles for Pharmaceutical Products, WHO] What Are the Different Types of Clinical Research? 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) 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. [1] Citations from the Federal Register are [volume] FR [page number] ([date]), e.g., 65 FR 741 (Jan. 6, 2000). Chemical TypeThe Chemical Type represents the newness of a drug formulation or a new indication for an existing drug formulation. The Act requires a firm who manufactures a biologic for sale in interstate commerce to hold a license for the product. Post-Market Surveillance - is the process by which a drug’s safety is monitored on an ongoing basis after a drug is approved by FDA. Consumer Medication Information (CMI) - Compared to a Medication Guide,  a Consumer Medication Information sheet  gives broader  information on how to use a medicine. Members of the research team regularly monitor the participant’s health to determine the study’s safety and effectiveness. Glucose is a form of sugar your body uses for energy. 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. MedWatch - MedWatch is FDA’s safety information and adverse event reporting program. 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. 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. 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). Composed of 27 Institutes and Centers, NIH provides leadership and financial support to researchers in every state and throughout the world. This and other terminology used by the FDA are updated and made available for download via the NCI File Transfer Protocol (FTP). These information sheets are prepared by pharmacies and given out with prescription drugs. Drug Product The finished dosage form that contains a drug substance, generally, but not necessarily in association with other active or inactive ingredients. From abbreviated new drug application to therapeutic equivalence codes, FDA defines it. For example, an experiment that is done in vivo is done in the body of a living organism. Sodium - an element that the body needs to work properly. ), 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. Risks, the bodies of people with an illness `` drugs '' therapeutic... 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