FDA Part 15 Hearing To Analyze Mandatory Electronic Submissions
This article was originally published in The Pink Sheet Daily
Executive Summary
Agency will host a public hearing Dec. 18 to solicit input on moving to an electronic filing platform, beginning with premarket submissions.
You may also be interested in...
FDA Internal IoM Task Force Will Release Findings In December
A commissioner office-level task force has been charged with evaluating recommendations issued by the Institute of Medicine.
With One Launch Under Way, SpringWorks Ramps Up For A Second
The company initiated a rolling submission with the US FDA for mirdametinib, a MEK inhibitor that is poised to be its second commercial product for a rare disease.
Mural Oncology Primed For IL-2 Readouts Next Year
The company, which Alkermes spun out last year, is now positioned as a pure-play oncology specialist with a focus on cytokines.