-
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.
Follow Us
REGULATORY CORNER
Welcome to PROMETRIKA’s Regulatory Corner. In this space, our experts will offer their insights in an approachable manner on specific initiatives from global regulatory authorities and discuss regulatory trends impacting the development of medical products. We hope you will check in regularly for these overviews.
Subscribe to Updates
