Complex Generics: Gottlieb Eyes FDA Policy Changes To Speed Approvals
US agency could reconsider requirement that instructions for use be same for branded and generic products, FDA Commissioner-nominee Scott Gottlieb suggests, while also leaving door open to statutory changes in Hatch-Waxman Act.
You may also be interested in...
A plurality of the questions from the Senate HELP Committee at Stephen Hahn's confirmation hearing to head the US FDA focused on drug development issues, despite the time lawmakers spent discussing the agency's regulation of e-cigarettes.
The idea could help quiet growing criticism over system gaming and high drug prices.