Posted by Michael Wonder on 07 Dec 2017
FDA seeks to speed approvals of generic drug-device combos
5 December 2017 - New FDA guidance will make it easier for generic companies to get drug-device combination products approved.
The final guidance will explain the issues generic applicants should consider when design differences between a generic version of a branded drug-device combination product could impact the clinical effect or safety profile of the generic product, FDA Commissioner Scott Gottlieb said recently.
Gottlieb, who spoke 28 November at the FDA’s Generic Drug Science Day, said as long as the generic applicant can demonstrate that the differences don’t affect the clinical effect or safety profile when the generic is substituted for the branded product, the generic can receive approval.
