Most trials currently use of frequentist statistics, but agency argues that Bayesian methods allow for better extrapolation.
Could drugmakers begin to more frequently explore the Bayesian approach into data extrapolation for pediatric product development?
The model was highly touted by FDA speakers at a Sept. 23 public workshop on pediatric master protocols cohosted by the agency and the University of Maryland Center of Excellence...
The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.
In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.
