Programs to Support Drug Development in Infectious Disease: GAIN, QIDP, and LPAD

Generating Antibiotic Incentives Now (GAIN) and the Qualified Infectious Disease Product (QIDP) designation and the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) were designed by the FDA to streamline development and encourage investment into targeting infections that lack effective therapies. Rho has provided regulatory strategy and submission support for products that have utilized these programs and other programs meant to spur development in infectious disease. Our regulatory experts can help guide sponsors through GAIN and the QIDP, LPAD, and other regulatory programs so more drugs that treat life-threatening infections can be developed and save lives.