investigational drug

A substance that has been tested in a laboratory and has gotten approval from the U.S. Food and Drug Administration (FDA) to be tested in people. A drug may be approved by the FDA for use in one disease or condition but be considered investigational in other diseases or conditions. Also called an experimental drug.

English dictionary of cancer terms . 2015.

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  • investigational new drug — in·ves·ti·ga·tion·al new drug in .ves ti gā shə nəl n a drug that has not been approved for general use by the Food and Drug Administration but is under investigation in clinical trials regarding its safety and efficacy first by clinical… …   Medical dictionary

  • investigational — adjective a) Of, or relating to investigating, or to an investigation. An expanded access protocol allows patients to benefit from an investigational drug prior to FDA approval. b) of, or relating to an unapproved drug or chemical entity being… …   Wiktionary

  • Drug development — Drug research redirects here. For the journal, see Drug Research (journal). Drug development is a blanket term used to define the process of bringing a new drug to the market once a lead compound has been identified through the process of drug… …   Wikipedia

  • Drug Price Competition and Patent Term Restoration Act — Acronym Hatch Waxman amendments Citations Codification …   Wikipedia

  • Drug-eluting stent — Intervention An example of a drug eluting stent. This is the TAXUS Express2 Paclitaxel Eluting Coronary Stent System, which releases paclitaxel. ICD 9 CM …   Wikipedia

  • Drug repositioning — (also known as Drug repurposing, Drug re profiling, Therapeutic Switching and Drug re tasking) is the application of known drugs and compounds to new indications (i.e., new diseases).[1] Contents 1 Drug repositioning 2 See also …   Wikipedia

  • Drug Master File — or DMF is a document prepared by a pharmaceutical manufacturer and submitted solely at its discretion to the appropriate regulatory authority in the intended drug market. There is no regulatory requirement to file a DMF. However, the document… …   Wikipedia

  • Investigational new drug — The United States Food and Drug Administration s investigational new drug (IND) program is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a …   Wikipedia

  • Investigational Device Exemption — An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or aPremarket Notification… …   Wikipedia

  • investigational — adjective Date: 1905 1. of or relating to investigation < investigational activities > 2. relating to or being a drug or medical procedure that is not approved for general use but is under investigation in clinical trials regarding its safety and …   New Collegiate Dictionary

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