Development of new anti-HIV drugs follows a dynamic regulatory process.Genereally speaking,the new anti-HIV drugs approval process in the U.S.A. consists of three principal elements or types of activities:(1) testing of safety and effectiveness through animal pharmacology/toxicology,chemistry/manufacturing/control,and human studies;(2) preparation and submission of the data obtained from hte above studies through the investigational new drug application (IND) and NDA (New Drug Application); and (3) evaluation of data contained in the IND and NDA submissions.
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