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. Privacy Policy - We have a strict privacy policy. Other words to describe clinical research are “clinical trial,” “protocol,” “study,” and “experiment.”. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. A researcher’s hope may also sway a participant’s response. FDA delays final approval of the generic drug product until all patent or exclusivity issues have been resolved. 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. Chemical TypeThe Chemical Type represents the newness of a drug formulation or a new indication for an existing drug formulation. Study - Conducted by a principal investigator who is often a doctor. 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). It is a comprehensive analysis of clinical trial data and other information prepared by FDA drug application reviewers. The control group may also be made up of healthy volunteers. 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”. The site is secure. The Drug Facts tell you what a medicine is supposed to do, who should or should not take it, and how to use it. Experiment - A study done to answer a question. If the NDA is approved, the product may be marketed in the United States. Placebo - An inactive pill. Results from the study will usually be presented in terms of trends or overall findings and will not mention any specific participants. Glossary of Terms Learn “FDA-Speak” The Food and Drug Administration has its own set of unique terminology, definitions, and regulatory requirements. 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. Information about the potential benefits and risks of taking the drug. Unlike people with type 1 diabetes, the bodies of people with type 2 diabetes make insulin. 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. If the information provided meets FDA requirements, the application is approved and a license is issued allowing the firm to market the product. A drug may be recalled due to factors such as problems with packaging, manufacturing, or contamination. Listed here are examples of some common terms for various commodity areas and their plain language definitions. the drug has already been approved but the company has requested to use it on a different patient population). New Drug Approval Process - After the animal testing stage, FDA decides whether it is reasonably safe for the company to move forward with clinical trials—studies that evaluate the safety and effectiveness of a drug in healthy people and in patients. Commonly Used Terms in Addiction Science A Abstinence: Not using drugs or alcohol. In vivo is the opposite of in vitro. 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.”. 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). It is a daily (except federal holidays) publication. 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. A tentative approval does not allow the applicant to market the generic drug product. Recalls are classified as Class I, Class II, or Class III. Therefore, they may be effective in the treatment of a condition, or they may not. 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. Drug products evaluated as "therapeutically equivalent" can be expected to have equal effect and no difference when substituted for the brand name product. 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. Therapeutic Biological ProductA therapeutic biological product is a protein derived from living material (such as cells or tissues) used to treat or cure disease. The supplement type refers to the kind of change that was approved by FDA. Double-blind research design helps minimize the placebo effect. Serious adverse events are those that can cause disability, are life-threatening, result in hospitalization or death, or are birth defects. 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). Experimental group - The group of participants in a study that receive the experimental or study intervention (such as medication or psychotherapy). 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. The site is secure. In vitro is the opposite of in vivo. 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. You have the same chance to be placed in any of the test groups. This and other terminology used by the FDA are updated and made available for download via the NCI File Transfer Protocol (FTP). Expand All | Collapse All. 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. 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. ofloxacin listen (oh-FLOK-suh-sin) An antibiotic drug used to treat infection. When an FDA regulatory action, such as cells or tissues ) used to treat or cure disease events those... 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