US to require authorised generic info in NDA annual reports
This article was originally published in Scrip
Executive Summary
The US FDAis proposing to require NDA holders submit certain information regarding authorised generic drugs in annual reports to the agency.
You may also be interested in...
CDER Planning Guidances On Single-Trial Approvals, Real-World Evidence
US FDA drugs center’s ambitious guidance agenda lists 105 new or revised guidances, most of which carried over from the prior year; new to the list are three guidances each on real-world data and individualized antisense oligonucleotide drug products, and a document focused on demonstrating efficacy with a single adequate and well-controlled trial.
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.
Need a specific report? 1000+ reports available
Buy Reports