Posted by Michael Wonder on 27 Jul 2022
FDA explains the ins and outs of real-time oncology review program in new guidance
26 July 2022 - Cancer drugs under development that show substantial promise over existing therapies and have simple study designs, as well as easy to interpret outcomes, may qualify for a head-start review from the US FDA.
While the drug will ultimately be reviewed under the same user fee time frame as other products, it may help speed up the review process for sponsors.
