RETROVIR'S® Phase IV research program has encompassed a number of well defined preclinical and clinical investigations. The studies were negotiated during the preapproval period of the New Drug Application (NDA) and the progress has been closely followed by a special Phase IV monitoring group which was established within the Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research. An overview of the program is provided, along with an evaluation of the impact on the drug development process for the drug
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