The drug being evaluated in the trial; this definition is synonymous with investigational new drug or investigational medicinal product.
An investigational drug may be approved by the FDA for use in one disease or condition but still be considered investigational in other diseases or conditions. Also called experimental drug, IND, investigational agent, and investigational new drug.
The Investigational Drug Service is a research pharmacy that maintains the control and accountability of investigational products.
§ 312.7 Promotion of investigational drugs. (a) Promotion of an investigational new drug. A sponsor or investigator, or any person acting on behalf
Investigators and IRBs must ensure that research (ie, clinical investigation) involving investigational drugs or biologics is conducted in accordance with
Disposition of unused supply of investigational drug. 312.60: General responsibilities of investigators. 312.61: Control of the investigational drug. 312.62: Investigator recordkeeping and record retention. 312.64: Investigator reports. 312.66: Assurance of IRB review. 312.68: Inspection of investigator's records and reports
Jump to: Investigational Drugs, Medical Devices. Investigational Drugs. What is Is your drug clinical investigation exempt from Investigational New Drug (IND)
FDA Requirements for New Drugs and Biologics Investigational new drug (IND) means a new drug or biological drug that is used in a clinical investigation.
Investigational new drug (IND) means a new drug or biological drug that is used in a clinical investigation.
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