2020 In Review: US FDA New Drug Office’s COVID-19 Response Aided By Reorganization
Executive Summary
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.
You may also be interested in...
US FDA’s Science Strategies Program Aims To Proactively Tackle Drug Development Hurdles
The goal of the Office of New Drugs’ initiative is to develop and execute, in a cross-disciplinary manner, strategic plans to address substantive development hurdles in specific therapeutic areas. This approach already has been used for non-healing, chronic wounds and is being expanded to neurodegenerative and rare diseases, OND’s Peter Stein tells the Pink Sheet.
FDA Creates Division To Support First Amendment Policy Development, Oversee Advertising Research
Multiple unfavorable court decisions have forced the agency to adjust its advertising enforcement strategies.
US FDA Wants Assessment Of New Drug Review ‘Culture’ Amid Modernization, Other Changes
The New Drug Review Program is seeking a contractor to survey employees on the impact of team culture on performance and overall effectiveness.