Political Appointees Shouldn't Influence Approval Decisions, Califf Says
Executive Summary
FDA commissioner offers new details about why he left final decision on Sarepta's controversial Duchenne muscular dystrophy drug to FDA's expert bureaucrats.
You may also be interested in...
The Case For US FDA To Be More Political In Its Approval Decisions
No one thinks it is a good idea for the US FDA Commissioner or some other higher up political actor to decide when and if to approve new drug applications. But it might not be so bad if the scientific staff at FDA paid a bit more attention to ‘political’ issues before making some decisions.
US FDA Wants Assessment Of New Drug Review ‘Culture’ Amid Modernization, Other Changes
The New Drug Review Program is seeking a contractor to survey employees on the impact of team culture on performance and overall effectiveness.
Califf Likely To Find Many Familiar Problems Upon Return To US FDA Helm
President Biden’s pick for FDA commissioner should remember many of the hot-button issues that he would face upon confirmation, such as drug pricing and approval standards.