FDA will hold antimicrobial resistance meeting
Executive Summary
On April 28, FDA will hold a public hearing to discuss strategies to limit the development of antimicrobial resistance and the possible effectiveness of economic incentives in promoting development of new antimicrobial agents. Under FDAAA, FDA is required to hold such a public hearing to discuss which life-threatening infectious diseases potentially qualify for grants and contracts under the Orphan Drug Act. In February, the agency was criticized by industry reps at a CAP workshop for not providing clear guidance on what it is looking for in anti-infective drug development, and not offering enough incentives for sponsors to continue R&D in the area