FDA misses approval deadline for milnacipran for fibromylagia
This article was originally published in Scrip
Executive Summary
Forest Laboratoriesand Cypress Bioscience are preparing for a first quarter US launch of their fibromylagia treatment milnacipran despite the US FDA's failure to act on the application by the October 18th user fee deadline.
You may also be interested in...
Keep Makena Under Accelerated Approval Pending More Studies, AMAG Tells US FDA
AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.
2020 In Review: US FDA New Drug Office’s COVID-19 Response Aided By Reorganization
Office of New Drugs Director Peter Stein tells the Pink Sheet that last phase of massive reorg was complicated by pandemic restrictions that forced review staff to work remotely, but the structural overhaul resulted in smaller, more nimble review groups and the breaking down of silos that ultimately helped the agency’s response to the public health crisis.
Postmarketing Safety Gets Closer Focus In Latest US FDA Drugs Center Reorganization
Division of Mitigation Assessment and Medication Error Surveillance will be established within the Office of Surveillance and Epidemiology, a change aimed at strengthening postmarketing oversight of opioids and other drugs; new Office of Safety and Clinical Evaluation will be created in Office of Generic Drugs, where Orange Book staff also will get their own division.
Need a specific report? 1000+ reports available
Buy Reports