Pharma Industry Broadens Its Approach To Expanded Access
Novartis co-leads industry forum on preapproval access that aims to share best practices and engage patient groups; Janssen is launching three pilots to leverage collection of preapproval access data.
You may also be interested in...
Many stakeholders interviewed by the GAO find the US FDA's updated guidance on treatment of adverse event data gathered under expanded access to be helpful, but some continue to be concerned that the data will be used to negatively impact development programs.
US FDA will continue expanded access activities as government shutdown continues, but CDER Director Woodcock says that platform trials can help eliminate the need for expanded access to exist.
NYU School of Medicine-led pilot program – created to evaluate requests for pre-approval access to Janssen's multiple myeloma drug Darzalex – blinds requests and evaluates them according to set of guiding principles.