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Drug Approval

More information in Books or onNLM PubMed
Definition: Process that is gone through in order for a drug to receive approval by a government regulatory agency. This includes any required pre-clinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance of the drug.  by govt regulatory agency, U.S. (not restricted to FDA) or foreign   
See Also Drugs, Investigational
Examples Compassionate Use Trials; Investigational New Drug Application
Other names New Drug Approval; Drug Approval Process; Processes, Drug Approval; Process, Drug Approval; New Drug Approvals; Drug Approvals, New; Drug Approvals; Drug Approval, New; Drug Approval Processes; Approvals, New Drug; Approvals, Drug; Approval, New Drug; Approval, Drug; Approval Processes, Drug; Approval Process, Drug; New Drug Approval Process; Food and Drug Administration Drug Approval Process; Food and Drug Administration Drug Approval

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Sources: NLM Medical Subject Headings, NIH UMLS, Drugs@FDA, FDA AERS original data copyright United States Government. No endorsement implied. Last modified 6/6/2012

Warning: the drugs or drug combinations referred to here may be similar or related, but are not be the same ones and may not have the same pharmacological action as other substances described on the same page or in the same row. Please refer to product monograph or to your doctor
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