Recent And Upcoming FDA Advisory Committee Meetings
Executive Summary
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
You may also be interested in...
Paratek's Omadacycline Get US Panel OK, But CABP Mortality Remains Concern
Most FDA advisory committee members say potential mortality issue seen in community acquired bacterial pneumonia patients can be addressed postmarket.
Insmed’s Amikacin Gains US FDA Panel Nod For Refractory Lung Disease
But advisory committee recommends against sponsor's broader indication that would include first-line use in adults with nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex; panel narrowly endorses surrogate endpoint of sputum culture conversion.
Fentanyl REMS May Need Better Surveillance Methods Before Possible Modifications
Sponsors currently use sources such as spontaneous adverse event reports to assess whether REMS for immediate-release fentanyl products is achieving its purpose, although such methods are limited in their ability to portray a clear picture.