Policy issues concerning antimicrobials: problems with the regulatory process governing their introduction.
Clinicians, representatives from industry, and independent observers have voiced complaints about the cumbersome and lengthy process employed by governmental regulatory agencies before approving new antimicrobials for marketing. The currently used drug approval process is probably not entirely appropriate for antimicrobials. In fact, the situation for antimicrobials is qualitatively so different from that of other drugs that antimicrobials should almost certainly undergo review specifically designed in accordance with such differences. Modifications in the pre- and postmarketing approval process for antimicrobials are proposed.
D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D004341:Drug Evaluation; D004352:Drug Resistance, Microbial; D005069:Evaluation Studies as Topic / Q000592:standards*; D006801:Humans; D011050:Policy Making; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration