investigational drug


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investigational drug

Abbreviation: IND
A drug available only for experimental purposes because its safety and effectiveness have not been proven.
Synonym: investigational new drug
See also: drug
References in periodicals archive ?
The other explains the regulations regarding how patients may be charged for investigational drugs.
The intent of the Bill is to amend the Federal Food, Drug and Cosmetic Act by requiring the sponsor of a covered investigational drug to publicize its expanded access policy.
WASHINGTON -- The Food and Drug Administration has published two rules to clarify the methods available to seriously ill patients interested in gaining access to investigational drugs and biologics when they are not ineligible for a clinical trial and lack other satisfactory treatment options.
These two rules clarify and improve FDA practices on investigational drugs, how they can be used prior to approval," Dr.
Historically, patients accessed promising investigational drugs once the agents were further along in the development process, typically around the time of Phase III trials.
84) Significantly, a sponsor, usually a pharmaceutical company, may not "commercialize an investigational drug by charging a price larger than that necessary to recover costs of manufacture, research, development, and handling of the investigational drug.
Moreover, the FDA has various powers: it can place the investigational drug on clinical hold if the study subjects are exposed to unreasonable and signifi cant risk; and it can terminate the trial if methods, facilities and controls used for manufacturing, processing or packaging are inadequate to establish and maintain appropriate standards of identity, strength, quality and purity as needed for subject safety.
If all goes well, an investigational drug will end up in a phase 3 study where several hundred people receive it for 6 months or longer.
Also, you should remember that even if you receive an investigational drug, it may not be helpful for you.
The FDA previously granted Orphan Drug Status to this investigational drug.
M2 PHARMA-September 11, 2013-MEI Pharm Inc buys exclusive worldwide rights to the investigational drug candidate PWT143(C)2013 M2 COMMUNICATIONS
The FDA would allow an investigational drug to be used to treat an individual patient if a licensed physician determines that the probable risk to the patient from the investigational drug is not greater than the probable risk from the patient's disease or condition, and the FDA determines that the patient cannot otherwise obtain the drug (eg the patient cannot participate in a clinical trial of the investigational drug).

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