US FDA seeks comments on draft guidance on user fee waivers, reductions and refunds
This article was originally published in SRA
Executive Summary
The US Food and Drug Administration has published for stakeholder comment draft guidance on how sponsors of drugs and biologicals can request user fee waivers, refunds or reductions1,2.
You may also be interested in...
US Orphan Fee Waiver Requests Must Include Much More Extensive Documentation
In update of 2011 draft guidance, FDA gives more detail on documentation needed for orphan sponsors to receive a program fee waiver; Guidance also suggests the agency is no longer working with SBA to make small business determinations.
Moment Of Truth In EU For Amarin’s ‘Multi-Billion-Dollar Opportunity’ Drug
The European Medicines Agency is expected to decide soon whether Amarin’s fish oil pill, Vascepa, should win pan-EU marketing approval for reducing cardiovascular risk.
EU Crunch Time For Two Drugs That Lost Their Fast-Track Status
Karyopharm and GSK should soon learn whether the European Medicines Agency will recommend EU approval for their respective products, selinexor and dostarlimab.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: