REGULATORY CORNER

As many of us are well aware, while single arm trials (SATs) historically have been accepted by the US FDA as primary evidence of efficacy for marketing approval in the setting of accelerated approval (AA) of new oncology agents/indications, their acceptance in other therapeutic areas including rare diseases has been more selective.

Participation of Regulatory Affairs professionals is integral to the timely and successful development of all therapeutic products. With our new offering of global Regulatory Affairs Consulting, we are strategically poised to provide fully integrated services from early development to marketing application approval to post-approval support.