Difference between revisions of "Investigational Drug~"
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| − | : A new drug for which an investigational new drug application has been filed with, and approved by the Food and Drug Administration (FDA). The drug may be a new chemical compound which has not been released for general use and is not available through regular channels of interstate commerce, or it may be an approved drug with a new use, different dosage level, different route of administration, or a new combination of drugs. Identified by the code “I” in the DEA, SPECIAL HDLG field (# 3) of the local DRUG file (#50). | + | : A new drug for which an investigational new drug [[application~|Application]] has been filed with, and approved by the Food and Drug Administration (FDA). The drug may be a new chemical compound which has not been released for general use and is not available through regular channels of interstate commerce, or it may be an approved drug with a new use, different dosage level, different route of administration, or a new combination of drugs. Identified by the code “I” in the DEA, SPECIAL HDLG field (# 3) of the local DRUG file (#50). |
Latest revision as of 14:26, 22 February 2012
- Investigational Drug
- A new drug for which an investigational new drug Application has been filed with, and approved by the Food and Drug Administration (FDA). The drug may be a new chemical compound which has not been released for general use and is not available through regular channels of interstate commerce, or it may be an approved drug with a new use, different dosage level, different route of administration, or a new combination of drugs. Identified by the code “I” in the DEA, SPECIAL HDLG field (# 3) of the local DRUG file (#50).
Source: Pharm: National Drug File V. 4.0 User Manual
| This is a Glossary term from the VistA Documentation Library |
