Regulatory experts note there has been an uptick in enforcement letters objecting to efficacy presentations in Rx drug promotions that are not consistent with FDA-required labeling. Panelists at FDLI meeting also discuss the use of real-world evidence in prescription drug promotion.

Almost 80% of novel agent submissions from the biggest companies were approved in recent years, compared with a 60% approval rate for the rest of the industry, according to a recent analysis of FDA approval decisions since 2021.

Almost 80% of novel agent submissions from the biggest companies were approved in recent years, compared with a 60% approval rate for the rest of the industry, according to a Pink Sheet analysis of FDA approval decisions since 2021.

A direct marketing authorization application to the UK medicines regulator offered a quicker route to approval for Novartis’ prostate cancer treatment Pluvicto than following the international Access Consortium process, because of the novel nature of the therapy, according to the company.