FDA's Califf On Real World Evidence: 'Use It For The Right Purposes'
This article was originally published in The Pink Sheet Daily
Executive Summary
Commissioner champions data from randomized clinical practice studies to support benefit/risk decisions but also sees value in other types of data generated outside the traditional clinical trial setting.
You may also be interested in...
Real-Word Evidence Generation System Will Be A Priority For Califf As FDA Commissioner
At his Senate confirmation hearing, Robert Califf said he wants to establish a system, built on electronic medical records, that can be used to more quickly confirm the benefits and risks of accelerated approval drugs.
Gottlieb: If Trials Show 'More Certain Benefit,' Risk Can Be Considered Long-Term
US FDA Commissioner says that with strong benefit shown, some risks can be discharged postmarket.
FDA Chief Scientist Post A Chance For Califf To Make Mark
Agency seeks candidates for the executive position in charge of its research policy apparatus.