Glossaries
Glossaries
| Term | Definition |
|---|---|
| pre-market approval application (PMA) |
An application to FDA for a license to market a new device in the United States.
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| pre-approval access |
A potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. NOTE: The intent is treatment, as opposed to research. Individual, Intermediate-size, and Widespread Use Expanded Access, also Emergency IND, are all programs administered under FDA guidelines. Additionally, the US Right-to-Try Act, which is independent of FDA, expands access. [FDA Expanded Access: Information for Physicians]
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| pragmatic trial |
A trial that compares health interventions in a diverse population representing clinical practice. These trials inform a clinical or policy decision by providing evidence for adoption of the intervention into real-world clinical practice. NOTE: These trials may or may not be randomized and can be large simple studies. [After GetReal - Project No. 115546l, WP1: Deliverable D1.3, Glossary of Definitions of Common Terms; Ford I, Norrie J. Pragmatic trials. N Engl J Med. 2016;375:454-63.] See also Real-World Data (RWD), Real-World Evidence (RWE), confirmatory trial.
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| postmarketing surveillance |
Ongoing safety monitoring of marketed drugs. See also Phase 4 studies, Phase 5 studies, pharmacovigilance.
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| postmarketing requirement (PMR) |
FDA-required postmarketing studies or clinical trials. [FDAAA; 21 CFR Part 314, subpart h; 21 CFR Part 601, subpart e] Compare to postmarketing commitment (PMC).
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| postmarketing commitment (PMC) |
Studies that a sponsor has agreed to conduct, but that are not required by a statue or regulation. [FDA Webpage Postmarketing Requirements and Commitments: Introduction, 01/12/2016] See also postmarketing requirement. Compare to postmarketing requirement (PMR).
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| population |
Any finite or infinite collection of subjects from which a sample is drawn for a study to obtain estimates for values that would be obtained if the entire population were sampled. [AMA style Manual]
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| platform trial design |
A type of trial design under a master protocol framework that tests multiple, targeted therapies that may be adapted over the course of the study. NOTE: Platform trials often include an adaptive design that may eliminate or add treatments based on interim analysis. These trials may also include elements of basket or umbrella trials and may have no pre-determined end date. [After Woodcock J, LaVange LM. Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both. N Engl J Med. 2017 Jul 6;377(1):62-70.; After US FDA, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry, 2022] See also master protocol, adaptive design.
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| plain language writing |
Writing in a way that helps readers understand the content in a document the first time they read it. Note: Plain writing is intended to be clear, concise, well-organized, and follow other best practices appropriate to the topic or field and the intended audience. [After Plain Writing Act of 2010, FDA]. See also health literacy.
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| placebo |
A pharmaceutical preparation that does not contain the investigational agent and is generally prepared to be physically indistinguishable from the preparation containing the investigational product.
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| phase 5 |
Postmarketing surveillance to monitor product safety and efficacy. See also outcomes research, phase, postmarketing surveillance.
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| phase 4 |
Post-approval studies to delineate additional information about the drug's risks, benefits, and optimal use that may be requested by regulatory authorities in conjunction with marketing approval. NOTE: Phase 4 studies could include, but would not be limited to, studying different doses or schedules of administration than were used in Phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time. [after FDA CDER handbook, ICH E8] See also phase.
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| phase 3b |
Later Phase 3 trial done near the time of approval to elicit additional findings. NOTE: Dossier review may continue while associated Phase 3b trials are conducted. These trials may be required as a condition of regulatory authority approval. Phase 3a is in common usage but not reflected in regulatory guidance. See also phase, phase 3.
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| phase 3 |
Phase that includes the controlled clinical trials intended to confirm safety and effectiveness, evaluate the overall benefit-risk relationship, and to provide substantial evidence for regulatory approval and labeling. NOTE: Phase 3 studies usually include from several hundred to several thousand subjects. [After ICH E8; Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Draft Guidance for Industry. December 2019] See also phase, phase 3b.
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| phase 2b |
Later Phase 2 trials, in transition to Phase 3, where the study populations more closely reflect the population, dosage, and condition for intended use. [Clarification of FDA Guidance for industry end of Phase 2a meetings, September 2009; Discussion in Peter B. Gilbert. SOME DESIGN ISSUES IN PHASE 2B VERSUS PHASE 3 PREVENTION TRIALS FOR TESTING EFFICACY OF PRODUCTS OR CONCEPTS. Stat Med. 2010 May 10; 29(10): 1061-1071.] See also phase, phase 2, phase 2a.
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