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.
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Drug Development Questions Dominate Hahn's Confirmation, Despite Talk About E-Cigs
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.
Gottlieb On Pursuing Legislative Reform: Start Small, Build Later
Former US FDA commissioner Scott Gottlieb encouraged stakeholders at the Association for Accessible Medicine's GRxBiosims 2019 meeting to start small in scope when pushing for legislative changes, which makes it easier to build on later.
Gottlieb Tells Brand Firms To Sell Samples For Generics – Or Face The Consequences
The idea could help quiet growing criticism over system gaming and high drug prices.