Glossaries
Glossaries
| Term | Definition |
|---|---|
| action letter |
An official communication from FDA to an NDA sponsor announcing an agency decision. See also approval letter, approvable letter, not-approvable letter.
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| acronym |
A word formed from the beginning letters (e.g., ANSI) or a combination of syllables and letters (e.g., MedDRA) of a name or phrase. NOTE: An acronym is usually pronounced as a word, not by speaking each letter individually. Compare to abbreviation
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| accelerated approval |
Regulatory mechanism by which new drugs meant to treat serious life-threatening diseases and that provide meaningful therapeutic benefit to patients over existing treatments can be approved rapidly. [after FDA, Guidance for Industry Expedited Programs for Serious Conditions - Drugs and Biologics; after NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource https://www.ncbi.nlm.nih.gov/books/NBK338448/]
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fast track designation |
| absorption |
The process by which medications reach the blood stream when administered other than intravenously, for example, through nasal membranes. See also ADME (pharmacokinetics).
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| abbreviation |
A set of letters that are drawn from a word or from a sequence of words and that are used for brevity in place of the full word or phrase. NOTE: An abbreviation is NOT pronounced as a word, but each letter is read in sequence (e.g., NIH). Compare to acronym.
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