Next Steps for Patient-Centered Drug Development: Room for More Input, With Limits
This article was originally published in RPM Report
Executive Summary
Patient advocates are pushing the Food & Drug Administration to take the next step in the agency’s patient-focused drug development initiative and more directly incorporate the patient experience into regulatory decisions. While that’s a welcomed ask, FDA officials say, it’s not as easy as it looks.
You may also be interested in...
Disease-Of-The-Quarter Club: FDA Plans 20 Patient Network Meetings Over Five Years
PDUFA V framework to involve patients in the creation of the risk-benefit criteria for various diseases kicks off before the legislation is even enacted.
Oncology Pilot To Highlight Disagreements Between US FDA And Sponsor For Advisory Committees
'Point/Counterpoint' program grew out of Assessment Aid initiative in the Oncology Center of Excellence and will be unveiled at an upcoming ODAC meeting.
US FDA Oncology Leadership Shuffle Moves Patricia Keegan To OCE; Gootenberg Takes On Recruitment
US FDA's reorganization of drug reviews splits Keegan's old OHOP division into two.
Existing Subscriber?
Sign in to continue reading.
Need a specific report? 1000+ reports available
Buy Reports
Need a specific report? 1000+ reports available
Buy Reports
New to Pink Sheet?
Start a free trial today!
Register for our free email digests:
Register for our free email digests: