Gottlieb details new initiatives to bolster generics sector

US Food and Drug Administration Commissioner Scott Gottlieb has outlined plans for two new initiatives to modernize aspects of the generic drug review process.

Since his appointment as FDA chief, Dr Gottlieb has been vocal in his support for the generics sector, pledging to expedite development by addressing scientific and regulatory obstacles to competition.

The new plans, which will be funded by $37.6 million from the US President’s 2019 budget request, come on top of a series of initiatives to promote the development of generic medicines in the USA, including new active surveillance systems and a new process for submitting generic drug applications for review.