www.fdanews.com/articles/184393-emd-serono-wins-fda-nod-for-redesigned-pen-injector
EMD Serono Wins FDA Nod for Redesigned Pen Injector
November 14, 2017
EMD Serono won the FDA’s approval for a redesigned version of its Gonal-f RFF Redi-ject pen injector.
First approved in 2013, the device is designed to inject follitropin alfra to induce ovulation and pregnancy in oligo-anovulatory women.
The redesigned pen was evaluated in a simulated-use study involving 86 women with infertility and 30 fertility nurses.