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VIII. Comments |

Development of Antibiotics

Norman W. Lavy, M.D.
Ann Intern Med. 1978;89(5_Part_2):864-865. doi:10.7326/0003-4819-89-5-864_4
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Dr. Sande has emphasized the importance of pursuing, through controlled clinical research, the optimal therapeutic regimens for a number of relatively specialized site-organism categories. Dr. Christensen noted that to satisfy current regulatory requirements in bringing new antibiotics to market, industry must repetitively evaluate the same indications, redeveloping essentially the same kinds of data, the same kinds of efficacy information. Dr. Crout confirmed that for antibiotics, as for all other drugs, the law and the regulations do require "substantial evidence," consisting of adequate and well-controlled studies, before approval and marketing.

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