by govt regulatory agency, U.S. (not restricted to FDA) or foreign
Scope Note
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.
Entry Term(s)
Drug Approval Process
Food and Drug Administration Drug Approval
Food and Drug Administration Drug Approval Process
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.