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AIDS DRUG INDS: 13% CURRENTLY SUBJECT TO CLINICAL HOLDS

Executive Summary

AIDS DRUG INDS: 13% CURRENTLY SUBJECT TO CLINICAL HOLDS, FDA Commissioner Young reported at the National Institute for Allergy and Infectious Diseases' AIDS Program Advisory Committee meeting Dec. 5. Of the 27 AIDS drugs now on clinical hold, over half (52%) are on hold for safety reasons, Young reported. The FDA Commissioner said the other clinical holds were a result of either "no scientific rationale" or "inadequate information." He explained that three of the INDs are on hold due to the absence of a scientific rationale, while 10 INDs are on hold due to insufficient information provided to FDA. Almost all of the AIDS drug INDs now on clinical hold were held up by FDA during Phase I or Phase II studies, Young noted. Of the 27 clinical holds, slightly less than half of the INDs were in Phase I studies, while just over half had reached Phase II studies. Only 7%, or two of the INDs, had reached the Phase III stage of investigation before being placed on clinical hold. The commissioner noted that in most cases the agency has been able to inform the sponsor of the information necessary to resolve the hold, and then evaluate the sponsors response, within a 30-day time frame.
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