Officials from the US Food and Drug Administration (FDA) explained how sponsors can increase their chances of getting accepted into the new model-integrated evidence (MIE) pilot program for generic drug applications. The program, which launched on 1 October, aims to expedite generic drug development.
Liang Zhao, director if the division of quantitative methods and modeling for FDA’s Office Research and Standards (ORS) in the Office of Generic Drugs (OGD), discussed the pilot at an 18 January workshop sponsored by the Small Business and Industry Assistance (SBIA) program…
