If advocacy groups are going to play a greater role in drug development, they need more access to sponsors' data and interactions with the US FDA, and more information about how the agency uses patient preference data, Parent Project Muscular Dystrophy rep says.
The increased role of the patient voice in drug development highlights the need for more transparency into sponsors' clinical data, their interactions with FDA and how the agency uses patient preference evidence in the drug review process, one advocacy group believes.
As the patient community takes on more responsibility for generating patient preference data, FDA should re-examine its policies on how...
The report gave examples of missed opportunities for innovation and patient access, as well as regulatory and operational problems that undermine the conduct of timely clinical trials in Europe.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
Japan looks set to press ahead with a reimbursement price cut for Eisai's Alzheimer's drug Leqembi following a cost-effectiveness review, despite differences with the company over methodology.
