FDA REMS Reforms Lacking Patient Engagement So Far
This article was originally published in The Pink Sheet Daily
As new repository website launches, agency acknowledges that it must do more to create patient-focused risk management.
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Office of Hematology and Oncology Products now has PRO leads in each clinical review division and is working more collaboratively with, rather than parallel to, the agency’s Study Endpoints and Labeling Development team to give sponsors consistent advice on use of PRO measures in trials.
Study everything together and a scale-up manufacturing after preliminary efficacy results, former FDA commissioners Gottlieb and McClellan and their coauthors recommend in a pair of white papers on how the US should respond to the coronavirus pandemic.
Pink Sheet Podcast: Understanding the White House Coronavirus Treatment Announcement, US FDA Postpones Domestic Inspections, Biologics Transition Day Arrives
Pink Sheet editor and reporters discuss the pending trials of chloroquine for use against coronavirus, expanded access for remdesivir, and the official move of several biologics from regulation as drugs to regulation as biologics.